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Hemostatic Metal Clip For The Gi Tract

FDA product code PKL · 61 cleared devices

Class 2 Gastroenterology, Urology
Regulation
21 CFR 876.4400
Review panel
GU
Implant
Yes
Life sustaining
Yes
Third party review
No
GMP exempt
No
Clearance span
1997-06-27 – 2026-09-14

Clip placement within the gastrointestinal (GI) tract for the purpose of endoscopic marking, hemostasis for mucosal/sub-mucosal defects, bleeding ulcers, arteries, polyps, diverticula in the colon, prophylactic clipping, anchoring feeding tubes, supplemental closure method of luminal perforations.

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