Data / Medical devices / United States / Cook Incorporated
Cook Incorporated: FDA-registered device maker in Spencer, IN, United States, 129 510(k) clearances and 1 PMA approval
Cook Incorporated is registered with the FDA (registration 1825146) in Spencer, IN, United States. It lists 100 device types. The FDA files 129 510(k) clearances and 1 PMA approval under its listings, the newest dated October 28, 2022. 9 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1825146
- Address
- 1100 W Morgan St, Spencer, IN, United States, 47460
- Owner or operator
- COOK, INC. (1820334)
- Roles
- Complaint file establishment, Contract manufacturer, Manufacturer, Manufacturer for export
- First device listed
- December 12, 1992
- Registered through
- 2026
- Brand names listed
- ACROBAT 2 CALIBRATED TIP WIRE GUIDE, ACROBAT CALIBRATED TIP WIRE GUIDE, AQ Hydrophilic Dual Lumen Ureteral Access Catheter, Aintree Intubation Catheter with Rapi-Fit Adapter, Amplatz Dilator, Amplatz Radiopaque TFE Sheath, Amplatz Renal Dilator Set, Amplatz Renal Introducer 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. Newest 100 of 129.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| October 28, 2022 | K223098 | Bakri Essential Postpartum Balloon | OQY | Substantially Equivalent | Cook Incorporated | accessdata.fda.gov |
| January 29, 2020 | K191498 | Cook-Cope Loop Nephrostomy Set, Ultrathane Nephrostomy Set with Mac-Loc, Ultrathane Suprapubic Set with Mac-Loc | LJE | Unknown | Cook Incorporated | accessdata.fda.gov |
| August 5, 2019 | K183323 | UPJ Occlusion Balloon Catheter | EYB | Unknown | Cook Incorporated | accessdata.fda.gov |
| July 16, 2019 | K183051 | Kaye Nephrostomy Tamponade Balloon Catheter and Stent Set | LJE | Unknown | Cook Incorporated | accessdata.fda.gov |
| June 26, 2019 | K191485 | Deflectable Brush Biopsy Set | FDX | Substantially Equivalent | Cook Incorporated | accessdata.fda.gov |
| June 17, 2019 | K182695 | Pigtail Ureteral Catheter Set, Sof-Flex AQ Coated Pigtail Ureteral Catheter | EYB | Unknown | Cook Incorporated | accessdata.fda.gov |
| May 29, 2019 | K182403 | Peel-Away Introducer | FED | Substantially Equivalent | Cook Incorporated | accessdata.fda.gov |
| May 17, 2019 | K191015 | Soft-Pass Embryo Mock Transfer Catheter Sets (Soft-Pass Embryo Mock Transfer Catheter Set and Soft-Pass Embryo Mock Transfer Catheter Set with Echogenic Tip) | MQF | Substantially Equivalent | Cook Incorporated | accessdata.fda.gov |
| May 17, 2019 | K183035 | Percutaneous Entry Set, Skinny Needle(R) with Chiba Tip, Disposable Two-part Trocar Needle | LJE | Unknown | Cook Incorporated | accessdata.fda.gov |
| May 1, 2019 | K182231 | Brush Biopsy Set ; Deflectable Brush Biopsy Set | FDX | Substantially Equivalent | Cook Incorporated | accessdata.fda.gov |
| April 23, 2019 | K181971 | Bander Ureteral Diversion Stent Set, Dretler Ureteroscopy Stent Set | FAD | Unknown | Cook Incorporated | accessdata.fda.gov |
| March 29, 2019 | K181770 | Intrauterine Access Balloon Catheter, Selective Salpingography Catheter | LKF | Substantially Equivalent | Cook Incorporated | accessdata.fda.gov |
| March 27, 2019 | K181735 | Percutaneous Neonatal Pigtail Nephrostomy Set, Pediatric Nephrostomy Stent Set | LJE | Unknown | Cook Incorporated | accessdata.fda.gov |
| January 18, 2019 | K181097 | Cook Cystostomy Catheter Set | KOB | Unknown | Cook Incorporated | accessdata.fda.gov |
| December 26, 2018 | K182709 | One-Step Suprapubic Introducer | KOB | Substantially Equivalent | Cook Incorporated | accessdata.fda.gov |
| November 23, 2018 | K180557 | Greene Renal Transplant Stent Set | FAD | Substantially Equivalent | Cook Incorporated | accessdata.fda.gov |
| October 30, 2018 | K182066 | O'Brien Suprapubic Introducer Set, Cook SP Tube Introducer Set | KOB | Unknown | Cook Incorporated | accessdata.fda.gov |
| October 26, 2018 | K180300 | Margolin HSG Cannula, Goldstein Sonohysterography Catheter | LKF | Substantially Equivalent | Cook Incorporated | accessdata.fda.gov |
| October 26, 2018 | K180291 | Cook Silicone Balloon HSG Catheter | LKF | Substantially Equivalent | Cook Incorporated | accessdata.fda.gov |
| October 24, 2018 | K180302 | Guardia Access Malleable Obturator, Guardia Obturator, Soft-Pass Obturator, Soft-Trans Malleable Obturator, Guardia ETS Embryo-Tested Syringe, Flushing Catheter | MQF | Substantially Equivalent | Cook Incorporated | accessdata.fda.gov |
| September 28, 2018 | K180216 | Seidmon Antegrade AQ Stent Set | FAD | Substantially Equivalent | Cook Incorporated | accessdata.fda.gov |
| September 21, 2018 | K180029 | Malecot Nephrostomy Catheter/Stent Set | FAD | Substantially Equivalent | Cook Incorporated | accessdata.fda.gov |
| September 14, 2018 | K180182 | Dual Lumen Ureteral Access Catheter, Flexi-Tip Dual Lumen Ureteral Access Catheter | EYB | Substantially Equivalent | Cook Incorporated | accessdata.fda.gov |
| September 13, 2018 | K180053 | Sof-Flex Ureteral Stent Set | FAD | Substantially Equivalent | Cook Incorporated | accessdata.fda.gov |
| August 17, 2018 | K181713 | Ultraxx Nephrostomy Balloon Catheter Set | LJE | Substantially Equivalent | Cook Incorporated | accessdata.fda.gov |
| July 30, 2018 | K181431 | Laser Ureteral Catheter | GEX | Substantially Equivalent | Cook Incorporated | accessdata.fda.gov |
| July 26, 2018 | K181712 | San Antonio Stopcock | ODC | Substantially Equivalent | Cook Incorporated | accessdata.fda.gov |
| July 12, 2018 | K180552 | Modified Novy Cornual Cannulation Set | MOV | Substantially Equivalent | Cook Incorporated | accessdata.fda.gov |
| June 28, 2018 | K181144 | Angled Tip Ureteral Catheter | KOD | Substantially Equivalent | Cook Incorporated | accessdata.fda.gov |
| May 24, 2018 | K180756 | Safety Wire Guide Introducer | EZN | Substantially Equivalent | Cook Incorporated | accessdata.fda.gov |
| May 2, 2018 | K180028 | Cook 810 Set, Desilets-Hoffman Introducer Set | EZN | Substantially Equivalent | Cook Incorporated | accessdata.fda.gov |
| April 23, 2018 | K171917 | Frova Intubating Introducer | BTR | Substantially Equivalent | Cook Incorporated | accessdata.fda.gov |
| April 19, 2018 | K172588 | Balloon Catheter and Balloon Ureteral Dilator Set | EZN | Unknown | Cook Incorporated | accessdata.fda.gov |
| April 13, 2018 | K173103 | Pivet and Soft-Pass Embryo Transfer Catheter Sets | MQF | Substantially Equivalent | Cook Incorporated | accessdata.fda.gov |
| April 11, 2018 | K173686 | Guardia Access Embryo Transfer Catheter Sets and Sydney IVF® Transfer Catheter | MQF | Substantially Equivalent | Cook Incorporated | accessdata.fda.gov |
| March 26, 2018 | K172017 | Black Silicone Filiform Double Pigtail Stent Set | FAD | Unknown | Cook Incorporated | accessdata.fda.gov |
| March 22, 2018 | K173105 | Endoscopic Cap, Check-Flo Adapter, Side-arm Adapter, Tuohy-Borst Adapter | ODC | Substantially Equivalent | Cook Incorporated | accessdata.fda.gov |
| March 7, 2018 | K171810 | Cone Tip Ureteral Catheter, Rutner Universal Wedge Catheter | KOD | Substantially Equivalent | Cook Incorporated | accessdata.fda.gov |
| February 23, 2018 | K171601 | Ultraxx Nephrostomy Balloon Catheter | LJE | Substantially Equivalent | Cook Incorporated | accessdata.fda.gov |
| February 15, 2018 | K171604 | Rösch Thurmond Fallopian Tube Catheterization Set, Fallopian Tube Catheterization Set, and Fallopian Tube Catheterization Wire Guide with Platinum Tip | LKF | Substantially Equivalent | Cook Incorporated | accessdata.fda.gov |
| February 1, 2018 | K171662 | Open-End Ureteral Catheter, Open-End Ureteral Catheter Sof-Flex, EchoTip Open-End Ureteral Catheter, Open-End Flexi-Tip Ureteral Catheter, Flexi-Tip Ureteral Catheter (Closed End), Whistle Tip Ureteral Catheter, Round Tip Ureteral Catheter, Spiral Tip Ureteral Access Catheter, Pediatric Ureteral Catheter | KOD | Substantially Equivalent | Cook Incorporated | accessdata.fda.gov |
| January 10, 2018 | K172051 | Guardia Access Nano and Soft-Trans Embryo Transfer Catheter Sets, Soft-Trans Embryo Transfer Catheter, Soft-Trans Guide Catheter | MQF | Substantially Equivalent | Cook Incorporated | accessdata.fda.gov |
| December 21, 2017 | K172321 | Shepard, Insemi-Cath, and Soft-Pass Coaxial - Cook Intrauterine Insemination Catheters | MQF | Substantially Equivalent | Cook Incorporated | accessdata.fda.gov |
| December 13, 2017 | K172217 | Flexor Ureteral Access Sheath and Flexor Parallel Rapid Release Ureteral Access Sheath | FED | Substantially Equivalent | Cook Incorporated | accessdata.fda.gov |
| November 22, 2017 | K172278 | Firlit-Kluge Urethral Stent, Koyle Diaper Stent, Zaontz Urethral Stent | GBM | Substantially Equivalent | Cook Incorporated | accessdata.fda.gov |
| October 26, 2017 | K172325 | Rhapsody H-30 Holmium Laser System | GEX | Substantially Equivalent | Cook Incorporated | accessdata.fda.gov |
| October 19, 2017 | K172527 | Amplatz Renal Dilator Set, Catheter for Use with Amplatz Renal Dilator Set, Amplatz Dilator, Amplatz Renal Introducer, Amplatz Radiopaque TFE Sheath, Clear Amplatz Sheath with Radiopaque Stripe | LJE | Substantially Equivalent | Cook Incorporated | accessdata.fda.gov |
| August 28, 2017 | K170010 | Salle Intraoperative Pyeloplasty Stent Set | FAD | Substantially Equivalent | Cook Incorporated | accessdata.fda.gov |
| August 11, 2017 | K162729 | Aintree Intubation Catheter, Arndt Airway Exchange Catheter Set, Cook Airway Exchange Catheter, and Cook Airway Exchange Catheter - Extra Firm With Soft Tip | BSR | Substantially Equivalent | Cook Incorporated | accessdata.fda.gov |
| July 28, 2017 | K171602 | Williams Cystoscopic Injection Needle | FBK | Substantially Equivalent | Cook Incorporated | accessdata.fda.gov |
| July 14, 2017 | K163318 | Soules Intrauterine Insemination Catheter | MQF | Substantially Equivalent | Cook Incorporated | accessdata.fda.gov |
| June 7, 2017 | K162109 | Kwart Retro-Inject Ureteral Stent | FAD | Substantially Equivalent | Cook Incorporated | accessdata.fda.gov |
| May 24, 2017 | K170603 | Tao Brush I.U.M.C. Endometrial Sampler | HFE | Substantially Equivalent | Cook Incorporated | accessdata.fda.gov |
| April 24, 2017 | K162104 | C-Flex Ureteral Stent Set | FAD | Unknown | Cook Incorporated | accessdata.fda.gov |
| January 27, 2017 | K161236 | Universa Firm Ureteral Stents and Stent Sets | FAD | Substantially Equivalent | Cook Incorporated | accessdata.fda.gov |
| June 24, 2016 | K160891 | Ultrathane Endoureterotomy Stent Set | FAD | Substantially Equivalent | Cook Incorporated | accessdata.fda.gov |
| January 11, 2016 | K151051 | Universa Soft Ureteral Stents and Stent Sets | FAD | Substantially Equivalent | Cook Incorporated | accessdata.fda.gov |
| March 18, 2015 | K133788 | COOK HOLMIUM LASER FIBER | GEX | Substantially Equivalent | Cook Incorporated | accessdata.fda.gov |
| November 18, 2014 | K140085 | UNIVERSA PERCULTANEOUS DRAINAGE CATHETER | FEW | Substantially Equivalent | Cook Incorporated | accessdata.fda.gov |
| July 1, 2013 | K124030 | COOK HOLMIUM LASER FIBER | GEX | Substantially Equivalent | Cook Incorporated | accessdata.fda.gov |
| May 22, 2013 | K130444 | H-30 HOLMIUM LASER SYSTEM | GEX | Substantially Equivalent | Cook, Inc. | accessdata.fda.gov |
| May 6, 2011 | K102141 | COOK WORD BARTHOLIN GLAND CATHETER (FINAL TRADE NAME NOT YET DETERMINED) | KNA | Substantially Equivalent | Cook Urological, Inc. | accessdata.fda.gov |
| April 23, 2010 | K100283 | VERSATUBE TAPERED TRACHEOSTOMY TUBE WITH DISPOSABLE INNER CANNULA, MULTIPLE, PREFIXES C-VT, C-VTIC | BTO | Substantially Equivalent | Cook, Inc. | accessdata.fda.gov |
| October 9, 2009 | K091767 | 3 WAY SILICONE FOLEY BALLOON CATHETER | EZL | Substantially Equivalent | Cook Urological, Inc. | accessdata.fda.gov |
| November 7, 2008 | K082066 | TAO BRUSH I.U.M.C. ENDOMETRIAL SAMPLER | HFE | Substantially Equivalent | Cook Urological, Inc. | accessdata.fda.gov |
| October 27, 2008 | K082536 | COOK WIRE GUIDES | OCY | Substantially Equivalent | Cook Urological, Inc. | accessdata.fda.gov |
| April 17, 2008 | K080525 | COOK ODYSSEY HOLMIUM LASER SYSTEM, MODEL 30W | GEX | Substantially Equivalent | Cook Urological, Inc. | accessdata.fda.gov |
| January 23, 2008 | K073496 | OPTILITE HOLMIUM LASER FIBERS | GEX | Substantially Equivalent | Cook Urological, Inc. | accessdata.fda.gov |
| November 20, 2007 | K072521 | COOK FIBER OPTIC BUNDLE AND FLEXOR DEFLECTING ACCESS SHEATH | FFS | Substantially Equivalent | Cook Urological, Inc. | accessdata.fda.gov |
| May 9, 2007 | K062475 | LMA STONEBREAKER DEVICE; PROBE SIZE 1.0MM, 1.6MM, 2.0MM | FFK | Substantially Equivalent | The Laryngeal Mask Co., Ltd. | accessdata.fda.gov |
| October 27, 2006 | K062438 | BAKRI POSTPARTUM BALLOON, MODEL J-SOS-100500 | KNA | Substantially Equivalent | Cook Ob/Gyn | accessdata.fda.gov |
| June 29, 2006 | K060908 | SONOHYSTEROGRAPHY BIOPSY DEVICE | PGK | Substantially Equivalent | Cook Urological, 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 |
| March 31, 2005 | K043418 | COOK PEDIATRIC FLEXOR URETERAL ACCESS SHEALTH | FED | Substantially Equivalent | Cook Urological, Inc. | accessdata.fda.gov |
| July 22, 2004 | K041544 | COOK SIDEARM CORE TISSUE BIOPSY DEVICE | KNW | Substantially Equivalent | Urological, Inc. | accessdata.fda.gov |
| April 6, 2004 | K040127 | COOK URETERAL BALLOON DILATION CATHETER SET | EZN | Unknown | Cook Urological, Inc. | accessdata.fda.gov |
| February 27, 2003 | K024050 | COOK NEPHROSTOMY DILATION BALLOON CATHETER SET | LJE | Substantially Equivalent | Cook Urological, Inc. | accessdata.fda.gov |
| February 5, 1999 | K983596 | INTRACYTOPLASMIC SPERM INJECTION (ICSI) MICRO-INJECTION PIPETTES, HOLDING PIPETTES, DENUDING PIPETTES, ASSISTED HATCHING | MQH | Substantially Equivalent | Cook Ob/Gyn | accessdata.fda.gov |
| February 1, 1999 | K983642 | COOK MINI-INCUBATOR | MQG | Substantially Equivalent | Cook Ob/Gyn | accessdata.fda.gov |
| December 21, 1998 | K983594 | EMBRYO TRANSFER CATHETERS/SETS | MQF | Substantially Equivalent | Cook Ob/Gyn | accessdata.fda.gov |
| December 21, 1998 | K983591 | INTRATUBAL TRANSFER SETS | MQF | Substantially Equivalent | Cook Ob/Gyn | accessdata.fda.gov |
| December 21, 1998 | K983590 | GIFT CATHETER SET/S | MQF | Substantially Equivalent | Cook Ob/Gyn | accessdata.fda.gov |
| December 16, 1998 | K983609 | COOK TEST TUBE HEATER | MQG | Substantially Equivalent | Cook Ob/Gyn | accessdata.fda.gov |
| July 14, 1997 | K963565 | MRI NEEDLES | FCG | Substantially Equivalent | Cook, Inc. | accessdata.fda.gov |
| October 18, 1996 | K961904 | AQ HYDROPHILIC DILATORS | KOE | Substantially Equivalent | Cook Urological, Inc. | accessdata.fda.gov |
| August 29, 1996 | K960263 | CERVICAL MUCOUS ASPIRATION CATHETER | HFC | Substantially Equivalent | Cook Urological, Inc. | accessdata.fda.gov |
| July 18, 1996 | K961933 | CIRCLE NEPHROSTOMY CATHETER SET | LJE | Substantially Equivalent | Cook Urological, Inc. | accessdata.fda.gov |
| June 11, 1996 | K962004 | AQ HYDROPHILIC UROLOGICAL CATHETERS | EYB | Substantially Equivalent | Cook Urological, Inc. | accessdata.fda.gov |
| May 28, 1996 | K961446 | AQ HYDROPHILIC STENT | FAD | Substantially Equivalent | Cook Urological, Inc. | accessdata.fda.gov |
| January 2, 1996 | K952527 | BALLOON UTERINE STENT | KNA | Substantially Equivalent | Cook Urological, Inc. | accessdata.fda.gov |
| December 19, 1995 | K954398 | INSEMI-CATH II | MFD | Substantially Equivalent | Cook Urological, Inc. | accessdata.fda.gov |
| July 28, 1995 | K931476 | NOVY CORNUAL CANNULATION SET | MOV | Substantially Equivalent | Cook Ob/Gyn | accessdata.fda.gov |
| May 25, 1995 | K951106 | SILICONE FOLEY CATHETER | EZL | Substantially Equivalent | Cook Urological, Inc. | accessdata.fda.gov |
| March 7, 1994 | K935874 | COOK COAGULATOR PROBE | GEI | Substantially Equivalent | Cook Urological, Inc. | accessdata.fda.gov |
| December 7, 1993 | K923729 | URETERAL CATHETER | EYB | Substantially Equivalent | Cook Urological, Inc. | accessdata.fda.gov |
| October 8, 1993 | K930135 | SILICONE RECTAL BALLOON | FEN | Substantially Equivalent | Cook Urological, Inc. | accessdata.fda.gov |
| July 9, 1993 | K930608 | ONIK-COHEN ACCESS SET | KOD | Substantially Equivalent | Cook Urological, Inc. | accessdata.fda.gov |
| June 7, 1993 | K923031 | ENDOSNARE | FDI | Substantially Equivalent | Cook Urological, Inc. | accessdata.fda.gov |
| March 22, 1993 | K926559 | PROACT BIOPSY NEEDLE ENCHANCEMENTS | FCG | Substantially Equivalent | Proact, Ltd. | accessdata.fda.gov |
| September 2, 1992 | K914150 | JANSEN-ANDERSON INSEMINATION SET | MFD | Substantially Equivalent | Cook Ob/Gyn | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| September 30, 1994 | P900007 | COOK CHORIONIC VILLUS SAMPLING SET | LLX | 5 | April 2, 2009 | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| December 13, 2010 | 57708 | Not yet classified | Terminated | Cook Urological, Inc. Koyle Diaper Stent 6.0 Fr, Sterile, GPN G17667, REF KDSCF-060050. | The firm received a complaint that 15 units of the Koyle Diaper Stent were received in packages that had not been sealed. Each stent should be sealed in a poly-Tyvek pouch. | accessdata.fda.gov |
| October 18, 2010 | 57352 | Not yet classified | Terminated | Cook Medical, Universa Soft Ureteral Stent and positioner, 6 Fr x 24 cm, REF USH-624-R, sterile, Cook Urological, Inc., Spencer IN. Used for temporary internal drainage from the ureteropelvic junction to the bladder. | The firm received a customer complaint that a box labeled as Universa Firm Stents but the box actually contained Universa Soft Stents. The inner product label is correct but the outer box is wrong. | accessdata.fda.gov |
| November 10, 2008 | 50223 | Not yet classified | Terminated | Cook Medical Universa Soft Ureteral Stent and Positioner with Hydrophilic Coating, 5.0Fr/26cm, sterile, Cook Urological Inc., Spencer, IN; REF USH-526-R, GPN REF G49966. The product was placed in a shipping box which is | "Soft" stents were placed in "firm" stent outer boxes. The soft stent is only to be left in the patient for 6 months, but the firm stent can be left in the patient for 12 months, so this error could result in the stent being left in the patient for longer than indicated for the device. | accessdata.fda.gov |
| July 31, 2008 | 48760 | Not yet classified | Terminated | Cook Urological Endoureterotomy Stent Set, 10Fr/13 cm, 6.0Fr/18 cm, sterile, Cook Urological, Inc., Spencer, IN; Ref EUSCFS-060018-10-13; GPN REF G18116. Ureteral stent. | The bond may break where the two materials meet, resulting in separation of the stent. | accessdata.fda.gov |
| June 29, 2007 | 38273 | Not yet classified | Terminated | Cook Urological Black Silicone Filiform Double Pigtail Ureteral Stent Set, 7.0Fr/24cm, sterile, Order Number (REF) 133724. | The radiographic band may detach from the stent and remain in the patient after removal of the stent. | accessdata.fda.gov |
| January 5, 2007 | 37115 | Not yet classified | Terminated | Cook Flexor DL Dual Lumen Ureteral Access Sheath with AQ Coating, sterile, REF FUS-095013-DL. | Lack of assurance of sterility, as the packages may not have been sealed. | accessdata.fda.gov |
| March 1, 2006 | 34671 | Not yet classified | Terminated | Cook Harrison fetal bladder stent set, sterile; REF J-HFBS-503540. | Instructions for Use (IFU) booklet missing pages 5-12. Pages 5-8 in English; 9-12 in Danish, describe stent duration, patient preparation, assembly, implanting, follow-up and removal instructions. IFU, device description, indications, contraindications, warnings, precautions, patient counseling, clinical usage, clinical study data, adverse events. One patien | accessdata.fda.gov |
| August 1, 2005 | 32912 | Not yet classified | Terminated | Cook brand Fascial Dilator; 10FR/37cm, sterile, Rx Only, Cook Ireland Ltd., Limerick, Ireland; REF G14191; Catalog No. 073710. | Mislabeled as to size. | accessdata.fda.gov |
| January 22, 2003 | 25427 | Not yet classified | Terminated | Pursuit ureteral dilation balloon catheters, 6 mm x 4 cm. Order # PAB-050080-6-4.0 | Product is labeled sterile, but was not sterilized. | accessdata.fda.gov |
Compare with other makers
- All makers of Catheter, Suprapubic (And Accessories)
- All makers of Connector, Catheter
- All makers of Collector, Ostomy
- All makers of Apparatus, Suction, Single Patient Use, Portable, Nonpowered
- All makers of Cannula, Intrauterine Insemination
- All makers of Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
Updated October 28, 2022. 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.