Device type
Hemostatic Metal Clip For The Gi Tract
Product code PKL · Class II · 21 CFR 876.4400 · Gastroenterology, Urology
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.
Recent 510(k)s
Oct 2, 2026
K261741
Hemostatic Clip
Anrei Medical (Hz) Co., Ltd.
- PKL
- Class II
Oct 2, 2026
K260487
stentFIX System Set (100.50n)
Ovesco Endoscopy AG
- PKL
- Class II
Sep 14, 2026
K253481
colonic FTRD Set (200.70); diagnostic FTRD Set (200.76); gastroduodenal FTRD Set (200.72)
Ovesco Endoscopy AG
- PKL
- Class II
Recent recalls
No recalls in the archive for PKL.