Data / Medical devices / United States / Wilson-Cook Medical Inc.
Wilson-Cook Medical Inc.: FDA-registered device maker in Winston Salem, NC, United States, 32 510(k) clearances
Wilson-Cook Medical Inc. is registered with the FDA (registration 1037905) in Winston Salem, NC, United States. It lists 24 device types. The FDA files 32 510(k) clearances under its listings, the newest dated September 29, 2025. 44 recall events name it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 1037905
- Address
- 4900 Bethania Station Rd, Winston Salem, NC, United States, 27105
- Owner or operator
- COOK ENDOSCOPY (9025083)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- May 24, 2001
- Registered through
- 2027
- Brand names listed
- ACCESSORY IRRIGATION ADAPTER, ACROBAT 2 CALIBRATED TIP WIRE GUIDE, ACUJECT VARIABLE INJECTION NEEDLE, ACUSNARE POLYPECTOMY SNARE, ACUSNARE POLYPECTOMY SNARE SOFT, BRONCHOSCOPE CYTOLOGY BRUSH, CAESAR GRASPING FORCEPS, CANNULATOME II PC DOUBLE LUMEN SPHINCTEROTOME and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 29, 2025 | K251104 | SureTome SW Sphincterotome with DomeTip | KNS | Substantially Equivalent | Wilson-Cook Medical | accessdata.fda.gov |
| April 26, 2022 | K213483 | SnapLoc Wire Lock | ODC | Substantially Equivalent | Wilson Cook Medical | accessdata.fda.gov |
| August 25, 2021 | K212323 | Instinct Plus Endoscopic Clipping Device | PKL | Substantially Equivalent | Wilson-Cook Medical, Inc. | accessdata.fda.gov |
| June 10, 2020 | K200972 | Hemospray Endoscopic Hemostat | QAU | Substantially Equivalent | Wilson-Cook Medical, Inc. | accessdata.fda.gov |
| February 27, 2020 | K200247 | Fusion Quattro Extraction Balloon | GCA | Substantially Equivalent | Wilson-Cook Medical, Inc. | accessdata.fda.gov |
| December 19, 2019 | K190829 | Gastrointestinal Injection Needles (VIN, LDVI, DVI and MHI) | FBK | Substantially Equivalent | Wilson-Cook Medical Inc./Cook Endoscopy | accessdata.fda.gov |
| December 13, 2019 | K193344 | Tri-Ex Extraction Balloon with Multiple Sizing | GCA | Substantially Equivalent | Wilson-Cook Medical, Inc. | accessdata.fda.gov |
| November 14, 2019 | K192908 | Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brushes | FDX | Substantially Equivalent | Wilson-Cook Medical, Inc. | accessdata.fda.gov |
| July 18, 2019 | K191048 | AcuSnare Polypectomy Snare - Duckbill | FDI | Substantially Equivalent | Wilson-Cook Medical, Inc. | accessdata.fda.gov |
| February 1, 2019 | K182319 | Glo-Tip Spray Catheter | OCX | Substantially Equivalent | Wilson-Cook Medical, Inc. | accessdata.fda.gov |
| January 25, 2019 | K182895 | Wilson-Cook Achalasia Balloon | PID | Substantially Equivalent | Wilson-Cook Medical, Inc. | accessdata.fda.gov |
| August 24, 2018 | K173673 | AcuSnare Polypectomy Snare | FDI | Substantially Equivalent | Wilson-Cook Medical, Inc. | accessdata.fda.gov |
| May 24, 2018 | K172665 | Classic Cotton Cannulatome®, CannulaTome II® Double Lumen Sphincterotome, Cotton CannulaTome II® PC, UTS® Ultra Taper Sphincterotome, Tri-Tome pc® Triple Lumen Sphincterotome, Howell D.A.S.H.® Sphincterotome with DomeTip®, Billroth II Sphincterotome, Soehendra® BII Sphincterotome, Models ACU-1 and ACU-1-VL active cords | KNS | Substantially Equivalent | Wilson-Cook Medical Inc./Cook Endoscopy | accessdata.fda.gov |
| April 17, 2018 | K172288 | Fusion OMNI Sphincterotome | KNS | Substantially Equivalent | Wilson-Cook Medical Inc./Cook Endoscopy | accessdata.fda.gov |
| March 28, 2018 | K171969 | Web II Memory Extraction Basket or Memory II Double Lumen Extraction Basket, Memory 5 Fr. Soft Wire Baskets or Memory Helical Stone Extractor, Memory Eight Wire Baskets or Memory Hard Wire Baskets, Fusion Wire Guided Extraction Basket, Non-Lithotripsy Extraction Basket | LQR | Substantially Equivalent | Wilson-Cook Medical, Inc. | accessdata.fda.gov |
| March 21, 2018 | K171973 | Captura® Disposable Hot Biopsy Forceps | KGE | Substantially Equivalent | Wilson-Cook Medical, Inc. | accessdata.fda.gov |
| March 20, 2018 | K171989 | Classic ERCP Catheter and Huibregtse-Katon ERCP Catheter and Huibregtse-Katon Angled, Glo-Tip ERCP Catheter, Glo-Tip II Double Lumen ERCP Catheter & w/ Radiopaque Bands, Fusion ERCP Catheter with DomeTip and Fusion OMNI ERCP Catheter with DomeTip, Haber RAMP Catheter, Soehendra Universal Catheter | ODD | Substantially Equivalent | Wilson-Cook Medical, Inc. | accessdata.fda.gov |
| February 21, 2018 | K163377 | Captura Disposable Bronchoscope Biopsy Forceps | EOQ | Substantially Equivalent | Wilson-Cook Medical, Inc. | accessdata.fda.gov |
| October 13, 2017 | K171548 | Cotton Graduated Dilation Catheter, Fusion Biliary Dilation Catheter, Soehendra Biliary Dilation Catheter, Geenen Graduated Dilation Catheter | FGE | Substantially Equivalent | Wilson-Cook Medical, Inc. | accessdata.fda.gov |
| August 17, 2017 | K171993 | Zimmon Needle Knife Papillotome | KNS | Substantially Equivalent | Wilson-Cook Medical Inc./Cook Endoscopy | accessdata.fda.gov |
| August 4, 2017 | K171596 | ECHO-3-22: Echotip Ultra and EUSN-1, EUSN-3: Echotip Ultrasound Needle | FCG | Substantially Equivalent | Wilson-Cook Medical, Inc. | accessdata.fda.gov |
| July 31, 2017 | K171607 | Bronchi and Gastrointestinal Cytology Brush | FDX | Substantially Equivalent | Wilson-Cook Medical Inc./Cook Endoscopy | accessdata.fda.gov |
| April 27, 2017 | K162142 | Accessory Irrigation Adapter | ODC | Substantially Equivalent | Wilson-Cook Medical, Inc. | accessdata.fda.gov |
| May 4, 2016 | K161203 | Soehendra Stent Retriever | FGE | Substantially Equivalent | Wilson-Cook Medical, Inc. | accessdata.fda.gov |
| January 5, 2007 | K063677 | FUSION QUATTRO EXTRACTION BALLOON XL | GCA | Substantially Equivalent | Wilson-Cook Medical, Inc. | accessdata.fda.gov |
| May 11, 2005 | K043203 | WILSON-COOK ENTERAL FEEDING TUBE, TIGER TUBE ENTERAL FEEDING TUBE | KNT | Substantially Equivalent | Wilson-Cook Medical, Inc. | accessdata.fda.gov |
| May 7, 2004 | K040981 | USW NEEDLEKNIFE PAPILLOTOME | KNS | Substantially Equivalent | Wilson-Cook Medical, Inc. | accessdata.fda.gov |
| February 27, 2004 | K040129 | TRI-EX EXTRACTION BALLOON WITH MULTIPLE SIZING | GCA | Substantially Equivalent | Wilson-Cook Medical, Inc. | accessdata.fda.gov |
| December 19, 2003 | K033203 | WILSON-COOK TRI-TOME SELECT PLUS | KNS | Substantially Equivalent | Wilson-Cook Medical, Inc. | accessdata.fda.gov |
| August 15, 1997 | K972674 | WILSON-COOK NEEDLE KNIFE PAPILLOTOME | KNS | Substantially Equivalent | Wilson-Cook Medical, Inc. | accessdata.fda.gov |
| September 19, 1995 | K953951 | WILSON-COOK TRIPLE LUMEN BALLOON STONE EXTRACTOR | GCA | Substantially Equivalent | Wilson-Cook Medical, Inc. | accessdata.fda.gov |
| March 28, 1994 | K936168 | WILSON-COOK BALLOON INFLATION DEVICE | KNT | Substantially Equivalent | Wilson-Cook Medical, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| August 20, 2026 | 99452 | Class II | Ongoing | Brand Name: HEMOSPRAY ENDOSCOPIC HEMOSTAT Product Name: HEMOSPRAY ENDOSCOPIC HEMOSTAT Model/Catalog Number: HEMO-7, HEMO-10, HEMO-7-EU, HEMO-10-EU Software Version: N/A Product Description: Hemostatic device for endoscop | Due to issue with endoscope adherence and inability to spray powder. Firm will provide an updated Instruction for Use (IFU). | accessdata.fda.gov |
| March 3, 2026 | 98488 | Class II | Ongoing | Instinct Plus Endoscopic Clipping Device REF: G58010 Rx Only, Sterile EO | Due to increased in complaints their is the potential for endoscopic clipping device to malfunction. | accessdata.fda.gov |
| December 18, 2025 | 98202 | Class II | Ongoing | Teslatome Bipolar Sphincterotomes REF: TESLA-B2535-260 Model Number: G60784 UDI-DI code: 00827002607842 REF: TESLA-B2535-450 Model Number: G60785 UDI-DI code: 00827002607859 These devices are used for cannulation of the | Due to product that may contain a void in the material that separates the wire guide and cutting wire lumens, which may cause an inappropriate path of current during cutting. | accessdata.fda.gov |
| December 15, 2025 | 98274 | Class II | Ongoing | Product Name: Nasal Jejunal Feeding Tube REF: NJFT-10 | Nasal feeding tube packaged without the nasal transfer tube component. | accessdata.fda.gov |
| October 31, 2024 | 95755 | Class II | Ongoing | Cook Medical HEMO-7-EU Hemospray Endoscopic Hemostat, REF G24663, 2.8 cm, sterile. | Specific lots of product have been manufactured with nonconforming raw materials resulting in the red activation knob cracking or breaking at the activation knob internal threading while the device is activated. | accessdata.fda.gov |
| August 29, 2024 | 95300 | Class II | Ongoing | Cook Medical Hemo-7 Hemospray Endoscopic Hemostat, REF G56572, 2.8 mm, Sterile; and Hemo-10 Hemospray Endoscopic Hemostat, REF G21049, 3.7 mm, Sterile. The device is used for hemostasis of nonvariceal gastrointestinal bl | Specific lots of product have been manufactured with nonconforming raw materials. | accessdata.fda.gov |
| November 3, 2023 | 93326 | Class II | Ongoing | QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-10X3, Order Number G22657; used to dilate strictures of the biliary tree | Nonconforming devices while manufactured correctly, do not comply to their design requirements. Potential harms associated with balloon detachment are endoscopic retrieval of an impacted or non-impacted object, bleeding caused by the retrieval device, or the incident can occur without injury and the object is left to pass naturally. | accessdata.fda.gov |
| June 22, 2023 | 92648 | Class II | Ongoing | Fusion Lithotripsy Extraction Basket, Model Number FS-LXB-2X4 G48277; Fusion Lithotripsy Extraction Baskets are intended to be used for endoscopic removal of biliary stones and foreign bodies. | Non-conforming product may appear in the field as inability to advance or retract the basket, or the drive wire breaking or separating from handle (with or without mechanical lithotripsy). | accessdata.fda.gov |
| May 22, 2023 | 92345 | Class II | Ongoing | Hemospray Endoscopic Hemostat: Reference Part Numbers: a) HEMO-7, REF G56572; b) HEMO-7-EU, REF G24663 | There are potential risks of the Hemospray powder adhering to the distal end of the endoscope, which can result in adhesion of the endoscope to tissue and consequent difficulty or inability to maneuver/remove the endoscope. | accessdata.fda.gov |
| February 4, 2020 | 84822 | Class II | Terminated | HEMO-7 Hemospray Endoscopic Hemostat | Complaints that the handle and/or activation knob on Hemostat devices have cracked or broken when the device is activated. In some cases, this has caused the carbon dioxide cartridge to exit the handle. Most of these complaints reported that the carbon dioxide cartridge exited the handle with minimal force. However, some complaints reported that the carbon d | accessdata.fda.gov |
| July 24, 2019 | 83395 | Class II | Terminated | Hemospray Endoscopic Hemostat | Potential for Hemospray device to be unable to spray powder due to misassembly of devices. | accessdata.fda.gov |
| June 14, 2019 | 83135 | Class II | Terminated | Acuject Variable Injection Needle | Potential for occluded injection needles. | accessdata.fda.gov |
| January 4, 2019 | 81956 | Class II | Terminated | Acusnare Polypectomy (Duck Bill Shaped) Snare Used with an electrosurgical unit for endoscopic polypectomy. | Complaints of the snare loop not completely retracting and/or misshaping of the snare loop. | accessdata.fda.gov |
| December 18, 2018 | 81875 | Class II | Terminated | COOK MEDICAL Captura SERRATED BIOPSY FORCEPS WITH SPIKE,2.4 mm, 230 cm, with Spike, DBF-2.4SN-230SP-20-S | The product is being recalled because Captura Serrated Forceps with Spike (DBF-2.4SN-230SP-20-S) were mislabeled as Captura Serrated Large Forcep-No Spike (DBF-2.4SL-230-20-S) and Captura Serrated Large Forcep-No Spike (DBF-2.4SL-230-20-S) were mislabeled as Captura Serrated Forceps with Spike (DBF-2.4SN-230SP-20-S). | accessdata.fda.gov |
| June 7, 2011 | 59039 | Not yet classified | Terminated | Disposable Hemostasis Clip, DCH-7-230, Rx only, Single Use only, Cook Medical Product Usage: This device is used for endoscopic clip placement within the gastrointestinal tract for the purpose of endoscopic marking, hemo | The disposable clip may not deploy after being positioned inside the patient. | accessdata.fda.gov |
| December 23, 2010 | 57573 | Not yet classified | Terminated | DPOC-15, Cholangioscopy Access Balloon, G54951, 15 mm, Rx only, Cook Medical, Winston-Salem, NC 27105 This device is intended to guide both optical and accessory devices for diagnostic and therapeutic applications during | Product defect; There is a risk of gastrointestinal perforation due to balloon deflation difficulty or air embolism resulting in poor patient outcomes including death. | accessdata.fda.gov |
| September 3, 2010 | 56808 | Not yet classified | Terminated | Ten Shooter Saeed Multi-Band Ligator, Rx Only, Wilson Cook Medical 4900 Bethania Station Road, Winston-Salem, NC 27105 This device is used to endoscopically ligate esophageal varices at or above the gastroesophageal junc | A section of the ligator barrel may separate from the barrels friction fit adapter that attaches to the patent end of the endoscope. This could result in a section of the ligator barrel detaching inside the patients gastrointestinal tract. | accessdata.fda.gov |
| July 24, 2009 | 52758 | Not yet classified | Terminated | Jejunal Feeding Set, Product Order number FLOWJ-9-20. This device is used for percutaneous endoscopic placement to provide enteral nutrition to patients requiring nutritional support. | The English only version of the Patient Care Manuals that accompany the device were shipped to a medical facility in Italy. | accessdata.fda.gov |
| June 12, 2009 | 52283 | Not yet classified | Terminated | Fusion Omni-Tome, Rx Only, Wilson Cook Medical, GI Endoscopy, 4900 Bethania Station Road, Winston-Salem, NC 27105. | The wire control port of these devices may be missing due to omission of a manufacturing activity. | accessdata.fda.gov |
| January 21, 2009 | 51176 | Not yet classified | Terminated | AcuSnare Polypectomy Soft Snare, Order number SASM-1, Wilson Cook Medical, GI Endoscopy, 4900 Bethania Station Road, Winston-Salem, NC 27105, packed 5 boxes, 10 units per box. This device is used with an electrosurgical | The snare head is hexagonal but the handle and packaging indicate an oval reorder number. | accessdata.fda.gov |
| October 30, 2008 | 50118 | Not yet classified | Terminated | FS-OMNI, Fusion Omni-Tome, Sterile, Rx only, Wilson Cook Medical, GI Endoscopy, 4900 Bethania Station Road, Winston-Salem, NC 27105, EC Representative: Cook Ireland Ltd, O'Haioran Road, National Technology Park, Limerick | The wire control port may have been omitted during manufacture. | accessdata.fda.gov |
| September 11, 2008 | 49518 | Not yet classified | Terminated | Zilver Expandable Metal Biliary Stent System, ZILBS-10-6, Stent Diameter: 10mm, Stent Length: 6cm, Introduction System: 7 FR., Disposable-Single Use Only, Rx Only, Cook GI Endoscopy, Winston-Salem, NC. The device is used | A section of the introduction system may detach after the stent has deployed. | accessdata.fda.gov |
| July 2, 2008 | 48970 | Not yet classified | Terminated | Cotton-Leung Biliary Stent., CLSO-10-5, Stent Diameter: 10 FR, Stent Length: 5cm, Disposable-Single use only, Rx Only, Wilson Cook Medical, GI Endoscopy, 4900 Bethania Station Road, Winston-Salem, NC 27105. Used to train | The product packaging label indicates the stent is 5cm, but the actual stent inside the packaging measures 10cm. | accessdata.fda.gov |
| January 24, 2007 | 37213 | Not yet classified | Terminated | Quantum TTC Biliary Balloon Dilation Catheter, Wilson Cook Medical, GI Endoscopy, 4900 Bethania Station Road, Winston-Salem, NC 27105 | The graphic label is incorrect, it lists 6mm/ 18FR. The product label is correct, it lists 10mm/ 30FR. | accessdata.fda.gov |
| October 5, 2006 | 36516 | Not yet classified | Terminated | Fusion OMNI ERCP Catheter, Wilson Cook Medical, GI Endoscopy, 4900 Bethania Station Road, Winston-Salem, NC 27105 | Injection through the flush port of these ERCP catheters may be compromised due to omission of a manufacturing activity. | accessdata.fda.gov |
| April 20, 2006 | 35265 | Not yet classified | Terminated | Cook Esophageal Dilator Set --------------------------------------Small label applied by OEM supplier: C CEDS 58 70 * Use By 2008/04 * Lot No. F1734513 * Sterile * Rx only * Cook *** Large product label applied at Cook E | Large product label contains an incorrect expiration date. | accessdata.fda.gov |
| January 5, 2006 | 34326 | Not yet classified | Terminated | SGD-12-70 Savary-Gilliard Dilator - Diameter: 12MM./36 FR. Length: 70 CM Reusable | The dilator size does not match the label on the product and product packaging. | accessdata.fda.gov |
| October 31, 2005 | 33945 | Not yet classified | Terminated | Fusion OMNI- GT * DOME TIP: ERCP Catheter: 6.0 FR./200 CM. 8 Minimum Accessory Channel: 4.2 MM * Disposable Single Use Only * Compatible Wire Guide:.035'' * Rx Only * Wilson-Cook Medical * GI Endoscope * 4900 Betharine S | Misbranded; The catheter size listed on the product label is 6 French, which is inaccurate. The catheter size is more accurately described as 7 French. | accessdata.fda.gov |
| June 9, 2005 | 32422 | Not yet classified | Terminated | CLBS-7-12 * Cotton-Leung Biliary Stent Set * Stent Diameter: 7 Fr. * Length (Between Flaps): 12 CM. * Standard Wire Guide:.035''/480 CM. * Pushing Catheter: 7 FR. * Disposable Single Use Only- Rx Only * Wilson-Cook Medic | The reorder number listed on the product label is inaccurate. | accessdata.fda.gov |
| April 1, 2005 | 31553 | Not yet classified | Terminated | ESD-5, ESD Flexible Endoscopic Suturing Device, Flexible Sew Right Device: Flexible TI Knot Device: External Accessory Channel: 6mm./75 cm.; * Suture Quickload Units (2); TI Knot Quickload Units (2) * Disposable Single U | The expiration date listed on the product label is greater than the vendor recommended expiration date. | accessdata.fda.gov |
| May 26, 2004 | 29196 | Not yet classified | Terminated | Nasal Jejunal Feeding Tube, Tube Diameter: 10 FR. Tube Length: 240CM., Disposable Single Use Only, Rx Only***COOK Wilson Cook Medical GI Endoscopy, 4900 Bethania Station Road, Winston-Salem, NC 27105 | The nasal transfer tube may be missing from the package of the affected lot. | accessdata.fda.gov |
| April 21, 2004 | 28905 | Not yet classified | Terminated | Biliary Stent Introducer Set | The guiding catheter provided with the SIS-10 biliary stent introduction system may be a 5 French instead of the required 6 French guiding catheter. | accessdata.fda.gov |
| April 21, 2004 | 28903 | Not yet classified | Terminated | AcuSnare Polypectomy Device, Cook Wilson-Cook Medical GI Endoscopy, 4900 Bethania Station Road, Winston-Salem, NC 27105. The SASM device prefix denotes Soft AcuSnare Mini. The ASM device prefix denotes Acu Snare Mini. Du | The snares inside the box labeled SASM-1 may actually be ASM-1 devices. The individual pouches may be correctly labeled ASM. | accessdata.fda.gov |
| January 15, 2004 | 28200 | Not yet classified | Terminated | Four Shooter Saeed Multi-Band Ligator | Product label lacks the symbols specifying the meaning of the manufacturing and expiration date. | accessdata.fda.gov |
| December 22, 2003 | 28011 | Not yet classified | Terminated | Oasis-One Action Stent Introduction System with ST-2 Soehendra Tannenbaum Biliary Stent, (11.5 French size only), Guiding Catheter: 6 FR, Minimum Accessory Channel Size: 3.7mm, Wire Guide Sold Separately, Disposable Sing | Mislabeling; Incorrect statement, Minimum Accessory Channel Size: 3.7mm, should state, Minimum Accessory Channel Size 4.2mm | accessdata.fda.gov |
| December 17, 2003 | 27958 | Not yet classified | Terminated | Howell D.A.S.H. II Access System, Wire Guided Sphincterotome | Wire-Guided Sphinterotomes may be packaged with an incorrect wire guide label. | accessdata.fda.gov |
| October 8, 2003 | 27449 | Not yet classified | Terminated | Brodmerkel Colon Decompression Set, CDSB-10, Catheter Diameter: 10 Fr. Catheter Length: 350 cm. Sideports: 10, Standard wire Guide:.035''/480 cm. Disposable Single use only, Rx Only. Cook, Wilson-Cook Medicl GI Endoscopy | Product may be packaged with an incorrect instructions for use (IFU) booklet. | accessdata.fda.gov |
| September 15, 2003 | 27261 | Not yet classified | Terminated | Quantum TTC Biliary Balloon Dilator | The product was labeled 'esophageal', but contained a 'biliary' ballon | accessdata.fda.gov |
| July 25, 2003 | 27462 | Not yet classified | Terminated | APSOF-7-4-RB, ZIMMON PANCREATIC STENT W/RADIOPAQUE BANDS, Stent Diameter: 7 FR., Length (Between Curl and Flap): 4 CM, For Use With Wilson-Cook Stent Introduction System: 7 FR. Minimum Accessory Channel Size: 2.8 MM., Di | The label is missing the Rx Only symbol. | accessdata.fda.gov |
| January 30, 2003 | 29853 | Not yet classified | Terminated | Esophageal Z-Stent Fully Coated or Uncoated Flanges, Endoprosthesis Systems with the Z Speed Introducer, Disposable Single Use Only, Rx Only, Sterile EO, Wilson-Cook Medical GI Endoscopy, 4900 Bethania Station Road, Wins | Label contains the 'Sterile EO' symbol, however the device is provided non-sterile. | accessdata.fda.gov |
| August 28, 2002 | 27445 | Not yet classified | Terminated | Howell D.A.S.H. Extraction Balloon, DASH-8.5-12-15, with Multiple Sizing, Catheter: 6 FR./200 CM., Shelf Life: 1 Year, Sterile, Disposable, Single Use Only, Wilson-Cook Medical, 4900 Bethania Station Road, Winston-Salem, | The product was labeled with a 5 year expiration date instead of a 1 year expiration date. | accessdata.fda.gov |
| August 21, 2002 | 27468 | Not yet classified | Terminated | ZILBS-8-6, ZILVER EXPANDABLE METAL BILIARY STENT SYSTEM, Stent Diameter: 8 MM. Stent Length: 6 CM., Accepts.035'' Wire Guide, Introduction system: 7 FR., Minimum Scope Channel: 2.8 MM., Disposable-Single Use Only, Rx Onl | Complaints were reported of difficulty in stent deployment. | accessdata.fda.gov |
| April 23, 2002 | 27461 | Not yet classified | Terminated | EUSN-19-QC Quick-Core Ultrasound Biopsy Needle, Specimen Notch: 20 MM.; Diameter: 5.2 FR. Tapered to 4.5FR. Length: CM. Adjustable Needle: 19 GA. Needle Extension: 0-8 CM. Adjustable Minimum Endoscope Channel: 2.0 MM. Di | There is a possibility that the affected devices would not capture a biopsy during a procedure. | accessdata.fda.gov |
| January 8, 2002 | 26966 | Not yet classified | Terminated | Spiral Z Expandable Metal Biliary Stent | The inner catheter of the introducer system may break after stent deployment. | accessdata.fda.gov |
Compare with other makers
- All makers of Endoscopic Irrigation/Suction System
- All makers of Hemostatic Metal Clip For The Gi Tract
- All makers of Stents, Drains And Dilators For The Biliary Ducts
- All makers of Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
- All makers of Endoscopic Cytology Brush
- All makers of Forceps, Biopsy, Electric
Updated September 16, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.