Data / Medical devices / United States / Cook Incorporated
Cook Incorporated: FDA-registered device maker in Ellettsville, IN, United States, 2 510(k) clearances
Cook Incorporated is registered with the FDA (registration 1000393132) in Ellettsville, IN, United States. It lists 78 device types. The FDA files 2 510(k) clearances under its listings, the newest dated July 1, 2014. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1000393132
- Address
- 6300 N. Matthews DR., Ellettsville, IN, United States, 47429
- Owner or operator
- COOK, INC. (1820334)
- Roles
- Complaint file establishment, Contract manufacturer, Contract sterilizer, Manufacturer
- First device listed
- December 12, 1992
- Registered through
- 2026
- Brand names listed
- 1,4 Layer Tissue Graft, ACCESSORY IRRIGATION ADAPTER, ACROBAT 2 CALIBRATED TIP WIRE GUIDE, ACROBAT CALIBRATED TIP WIRE GUIDE, ACUJECT VARIABLE INJECTION NEEDLE, Acusnare Polypectomy Snare, Acusnare Polypectomy Snare Soft, Advance, 14LP Low Profile PTA Balloon Dilatation Catheter and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|
| Accessory, Assisted Reproduction | MQG | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Adaptor, Catheter | GCE | 1 | Contract sterilizer | accessdata.fda.gov |
| Barrier, Animal Source, Intraoral | NPL | 2 | Contract sterilizer | accessdata.fda.gov |
| Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection | GCA | 2 | Contract sterilizer | accessdata.fda.gov |
| Biopsy Needle | FCG | 2 | Contract sterilizer | accessdata.fda.gov |
| Bronchoscope (Flexible Or Rigid) | EOQ | 2 | Contract sterilizer | accessdata.fda.gov |
| Cannula, Manipulator/Injector, Uterine | LKF | 2 | Contract sterilizer | accessdata.fda.gov |
| Catheter, Angioplasty, Peripheral, Transluminal | LIT | 2 | Contract sterilizer | accessdata.fda.gov |
| Catheter, Assisted Reproduction | MQF | 2 | Contract sterilizer | accessdata.fda.gov |
| Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | DWF | 2 | Contract sterilizer | accessdata.fda.gov |
| Catheter, Continuous Flush | KRA | 2 | Contract sterilizer | accessdata.fda.gov |
| Catheter, Embolectomy | DXE | 2 | Contract sterilizer | accessdata.fda.gov |
| Catheter, Irrigation | GBX | 1 | Contract sterilizer | accessdata.fda.gov |
| Catheter, Nephrostomy | LJE | U | Contract sterilizer | accessdata.fda.gov |
| Catheter, Ureteral, Gastro-Urology | EYB | 2 | Contract sterilizer | accessdata.fda.gov |
| Catheter, Urological | KOD | 2 | Contract sterilizer | accessdata.fda.gov |
| Cuff, Nerve | JXI | 2 | Contract sterilizer | accessdata.fda.gov |
| Device, Vascular, For Promoting Embolization | KRD | 2 | Contract sterilizer | accessdata.fda.gov |
| Dilator, Catheter | GCC | 1 | Contract sterilizer | accessdata.fda.gov |
| Dilator, Catheter, Ureteral | EZN | 2 | Contract sterilizer | accessdata.fda.gov |
| Dilator, Esophageal | KNQ | 2 | Contract sterilizer | accessdata.fda.gov |
| Dilator, Urethral | KOE | 2 | Contract sterilizer | accessdata.fda.gov |
| Dilator, Vessel, For Percutaneous Catheterization | DRE | 2 | Complaint file establishment, Contract sterilizer, Manufacturer | accessdata.fda.gov |
| Dislodger, Stone, Basket, Ureteral, Metal | FFL | 2 | Contract sterilizer | accessdata.fda.gov |
| Dislodger, Stone, Biliary | LQR | 2 | Contract sterilizer | accessdata.fda.gov |
| Dura Substitute | GXQ | 2 | Contract sterilizer | accessdata.fda.gov |
| Endoscope Channel Accessory | ODC | 2 | Contract sterilizer | accessdata.fda.gov |
| Endoscopic Access Overtube, Gastroenterology-Urology | FED | 2 | Contract sterilizer | accessdata.fda.gov |
| Endoscopic Cytology Brush | FDX | 2 | Contract sterilizer | accessdata.fda.gov |
| Endoscopic Grasping/Cutting Instrument, Non-Powered, Exempt | PTS | 2 | Contract sterilizer | accessdata.fda.gov |
| Endoscopic Guidewire, Gastroenterology-Urology | OCY | 2 | Contract sterilizer | accessdata.fda.gov |
| Endoscopic Injection Needle, Gastroenterology-Urology | FBK | 2 | Contract sterilizer | accessdata.fda.gov |
| Endoscopic Irrigation/Suction System | OCX | 2 | Contract sterilizer | accessdata.fda.gov |
| Endoscopic Retrograde Cholangiopancreatography (Ercp) Cannula | ODD | 2 | Contract sterilizer | accessdata.fda.gov |
| Flowmeter, Blood, Cardiovascular | DPW | 2 | Contract manufacturer | accessdata.fda.gov |
| Forceps, Biopsy, Electric | KGE | 2 | Contract sterilizer | accessdata.fda.gov |
| Forceps, Wire Holding | HYA | 1 | Contract sterilizer | accessdata.fda.gov |
| Instrument, Biopsy | KNW | 2 | Contract sterilizer | accessdata.fda.gov |
| Instrument, Manual, Surgical, General Use | MDM | 1 | Contract sterilizer | accessdata.fda.gov |
| Instrument, Surgical, Disposable | KDC | 1 | Contract sterilizer | accessdata.fda.gov |
| Instruments, Surgical, Cardiovascular | DWS | 1 | Contract manufacturer | accessdata.fda.gov |
| Intracardiac Patch Or Pledget, Biologically Derived | PSQ | 2 | Contract sterilizer | accessdata.fda.gov |
| Introducer, Catheter | DYB | 2 | Contract sterilizer | accessdata.fda.gov |
| Lithotriptor, Biliary Mechanical | LQC | 2 | Contract sterilizer | accessdata.fda.gov |
| Marker, Radiographic, Implantable | NEU | 2 | Contract sterilizer | accessdata.fda.gov |
| Mesh, Surgical | FTM | 2 | Contract sterilizer | accessdata.fda.gov |
| Mesh, Surgical, Collagen, Diaphragmatic Hernia | OWV | 2 | Contract sterilizer | accessdata.fda.gov |
| Mesh, Surgical, Collagen, Fistula | OXN | 2 | Contract sterilizer | accessdata.fda.gov |
| Mesh, Surgical, Collagen, Large Abdominal Wall Defects | OXK | 2 | Contract sterilizer | accessdata.fda.gov |
| Mesh, Surgical, Collagen, Plastic And Reconstructive Surgery | OXH | 2 | Contract sterilizer | accessdata.fda.gov |
| Mesh, Surgical, Collagen, Staple Line Reinforcement | OXE | 2 | Contract sterilizer | accessdata.fda.gov |
| Mesh, Surgical, Non-Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed | PAJ | 2 | Contract sterilizer | accessdata.fda.gov |
| Mesh, Surgical, Non-Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator | PAG | 2 | Contract sterilizer | accessdata.fda.gov |
| Mesh, Surgical, Polymeric | FTL | 2 | Contract sterilizer | accessdata.fda.gov |
| Micromanipulators And Microinjectors, Assisted Reproduction | MQJ | 2 | Contract sterilizer | accessdata.fda.gov |
| Microtools, Assisted Reproduction (Pipettes) | MQH | 2 | Contract manufacturer | accessdata.fda.gov |
| Needle, Conduction, Anesthetic (W/Wo Introducer) | BSP | 2 | Contract sterilizer | accessdata.fda.gov |
| Needle, Emergency Airway | BWC | 2 | Contract sterilizer | accessdata.fda.gov |
| Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene | DXZ | 2 | Contract sterilizer | accessdata.fda.gov |
| Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material) | KHJ | 2 | Contract sterilizer | accessdata.fda.gov |
| Port & Catheter, Implanted, Subcutaneous, Intravascular | LJT | 2 | Contract manufacturer, Contract sterilizer | accessdata.fda.gov |
| Powered Laser Surgical Instrument | GEX | 2 | Contract sterilizer | accessdata.fda.gov |
| Prosthesis, Eyelid Spacer/Graft, Biologic | NXM | 2 | Contract sterilizer | accessdata.fda.gov |
| Retrograde Intubation Set | QCX | 2 | Contract sterilizer | accessdata.fda.gov |
| Scissors, General, Surgical | LRW | 1 | Contract sterilizer | accessdata.fda.gov |
| Snare, Flexible | FDI | 2 | Contract sterilizer | accessdata.fda.gov |
| Stent, Ureteral | FAD | 2 | Contract sterilizer | accessdata.fda.gov |
| Stents, Drains And Dilators For The Biliary Ducts | FGE | 2 | Contract manufacturer, Contract sterilizer | accessdata.fda.gov |
| Stylet, Catheter | DRB | 2 | Contract sterilizer | accessdata.fda.gov |
| Stylet, Surgical, General & Plastic Surgery | GAH | 1 | Contract sterilizer | accessdata.fda.gov |
| Syringe, Irrigating (Non Dental) | KYZ | 1 | Contract sterilizer | accessdata.fda.gov |
| Transducer, Ultrasonic | JOP | 2 | Contract manufacturer, Contract sterilizer | accessdata.fda.gov |
| Transducer, Ultrasonic, Diagnostic | ITX | 2 | Contract manufacturer, Contract sterilizer | accessdata.fda.gov |
| Tube, Gastro-Enterostomy | KGC | 2 | Contract sterilizer | accessdata.fda.gov |
| Tube, Tracheal (W/Wo Connector) | BTR | 2 | Contract sterilizer | accessdata.fda.gov |
| Unit, Electrosurgical, Endoscopic (With Or Without Accessories) | KNS | 2 | Contract sterilizer | accessdata.fda.gov |
| Wire, Guide, Catheter | DQX | 2 | Contract sterilizer | accessdata.fda.gov |
| Wound Dressing With Animal-Derived Material(S) | KGN | U | Contract sterilizer | accessdata.fda.gov |
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 |
|---|
| July 1, 2014 | K141148 | EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET, EVOLUTION SHORTIE RL CONTROLLED-ROTATION DILATOR SHEATH SET | DRE | Substantially Equivalent | Cook Vascular, Inc. | accessdata.fda.gov |
| February 1, 1999 | K983642 | COOK MINI-INCUBATOR | MQG | Substantially Equivalent | Cook Ob/Gyn | accessdata.fda.gov |
Compare with other makers
Updated July 1, 2014. 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.