Hemostatic Metal Clip For The Gi Tract

FDA product code PKL · Class 2 · Gastroenterology, Urology

822

Registered devices

7,146

Adverse events

Recalls

510(k) clearances

Devices with this code

Date	Firm	Reason
2026-03-03	Wilson-Cook Medical Inc.	Due to increased in complaints their is the potential for endoscopic clipping device to malfunction.
2023-05-04	Olympus Corporation of the Americas	Complaints on clip deployment occurring during clinical procedures, leading to hazardous situations where clips fail to achieve their expected function or deplo
2023-05-04	Olympus Corporation of the Americas	Complaints on clip deployment occurring during clinical procedures, leading to hazardous situations where clips fail to achieve their expected function or deplo
2023-05-04	Olympus Corporation of the Americas	Complaints on clip deployment occurring during clinical procedures, leading to hazardous situations where clips fail to achieve their expected function or deplo
2023-05-04	Olympus Corporation of the Americas	Complaints on clip deployment occurring during clinical procedures, leading to hazardous situations where clips fail to achieve their expected function or deplo
2019-02-04	US Endoscopy Group Inc	Potential esophageal laceration during a patient procedure

Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.