NA
Hangzhou AGS MedTech Co., Ltd. · Model AG-5101-1950-090 · UDI-DI 06959664914014
PKL
Prescription
10
510(k) clearances
7,146
Adverse events (25 deaths)
6
Recalls
54
Facilities
Recalls
| 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 deploy incorrectly, poten |
| 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 deploy incorrectly, poten |
| 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 deploy incorrectly, poten |
| 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 deploy incorrectly, poten |
| 2019-02-04 | US Endoscopy Group Inc | Potential esophageal laceration during a patient procedure |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.