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FDA PRODUCT CODE · CLASS II

PKL — Hemostatic Metal Clip For The Gi Tract

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.

DEVICE CLASS
Class II
REGULATION
21 CFR 876.4400
MEDICAL SPECIALTY
Gastroenterology, Urology
REVIEW PANEL
GU
✓ Implant✓ Life-sustaining— GMP-exempt— Third-party review eligible
9
510(K)/PMA CLEARANCES
510k: 9
0
RECALL ENTRIES

Recent clearances

K260580Olympus Medical Systems Corp. · 510k2026-05-21
K252270Hangzhou AGS MedTech Co., Ltd. · 510k2026-04-08
K253734Taurus Endoscopy · 510k2026-03-12
K251562Ovesco Endoscopy AG · 510k2025-12-18
K252271Hangzhou AGS MedTech Co., Ltd. · 510k2025-11-12
K250229Micro-Tech (Nanjing) Co., Ltd. · 510k2025-09-08
K250842STERIS Corporation · 510k2025-04-18
K250066Boston Scientific Corporation · 510k2025-02-06

Related on SPEQ

Medical devices industry →Medical device quality (ISO 13485) →FDA device clearances →FDA enforcement & recalls →

Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.

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