Wilson-Cook Medical Inc./Cook Endoscopy
United StatesFDA applicant, unverified
- Devices
- 6
What Wilson-Cook Medical Inc./Cook Endoscopy makes
Wilson-Cook Medical Inc./Cook Endoscopy manufactures disposable and reusable endoscopic devices for gastrointestinal and bronchoscopy procedures, including hemostasis chips, sphincterotomes, cytology brushes, and injection needles. Their product line includes specialized tools like the Cotton Cannulatome®, ECHOTIP® Ultra Fiducial Needle, and various sphincterotome variants designed for precise tissue management and biopsy sampling. The company also supplies bronchoscopy and gastrointestinal cytology brushes for diagnostic collection.
The portfolio consists of Class II medical devices, regulated under the FDA’s 510(k) clearance pathway. These devices are listed in the FDA’s 510(k) registry, reflecting their compliance with U.S. regulatory requirements. The manufacturer operates from the United States.
Catalogue
Disposable Hemostasis Chip Ref K121505
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Echotip(R) Ultra Fiducial Needle Ref K111895
Regimes: 510(k) Registry: 510(k)Bronchi and Gastrointestinal Cytology Brush Ref K171607
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Fusion OMNI Sphincterotome Ref K172288
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Wilson-Cook Medical Inc./Cook Endoscopy have in the registry?
The registry currently lists 6 devices for Wilson-Cook Medical Inc./Cook Endoscopy. Devices recorded under merged duplicate company entries are counted once.
Which registries list Wilson-Cook Medical Inc./Cook Endoscopy's devices?
Among its 6 most recently registered devices, Wilson-Cook Medical Inc./Cook Endoscopy has devices listed in FDA 510(k) (6 devices).
What risk classes do Wilson-Cook Medical Inc./Cook Endoscopy's devices fall under?
Among its 6 most recently registered devices, the classes recorded for Wilson-Cook Medical Inc./Cook Endoscopy's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Wilson-Cook Medical Inc./Cook Endoscopy in the registry?
The most recently registered devices listed for Wilson-Cook Medical Inc./Cook Endoscopy include DISPOSABLE HEMOSTASIS CHIP, 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, ECHOTIP(R) ULTRA FIDUCIAL NEEDLE and Bronchi and Gastrointestinal Cytology Brush.