PKL

Hemostatic Metal Clip For The Gi Tract

Product code

PKL

Device name

Hemostatic Metal Clip For The Gi Tract

Device class

Class 2

21 CFR

21 CFR 876.4400

Medical specialty

Gastroenterology, Urology

Marketing pathway

510(K)

Flag

Implant

Flag

Life-sustaining / life-supporting

510(k) clearances (last 3 years)

18

Summaries archived here

17 (direct download)

510(k) clearances (all years, FDA)

64 (all years; only the last 3 years are listed here)

FDA classification definition

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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (18)

Last three years. Most recent: 2026-08-10.

17 summaries are archived here for direct download.