PKLClass II

Hemostatic Metal Clip For The Gi Tract

21 CFR 876.4400 / Gastroenterology, Urology

PKL is the FDA product code for Hemostatic Metal Clip For The Gi Tract, a class II device type, regulated under 21 CFR 876.4400. FDA's definition for this code reads: "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". As of 2026-09-10, FDA records hold 64 510(k) clearances under this code, the most recent dated 2026-08-10, and 6 recalls.

Classification record

Product code: PKL
Device name: Hemostatic Metal Clip For The Gi Tract
FDA 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.
Regulation: 21 CFR 876.4400
Device class: Class II
Review panel: Gastroenterology, Urology
Submission type: 510(k)
Implant: Yes
Life sustaining or supporting: Yes
GMP exempt: No
Third party review eligible: No
Ingested clearances: 65
Ingested recalls: 6

Clearances, product code PKL

By decision year

65 clearances under product code PKL with a decision year between 1997 and 2026, 2022 the highest year at 9.

Show the numbers

510(k) clearances under FDA product code PKL by decision year
Year	Clearances
1997	1
1999	1
2002	1
2003	1
2010	2
2012	3
2013	2
2014	1
2015	3
2016	1
2017	2
2018	5
2019	4
2020	6
2021	2
2022	9
2023	2
2024	8
2025	6
2026	5

Applicants with the most clearances

Product code PKL

Applicants holding the most 510(k) clearances under product code PKL
Applicant	Clearances
Boston Scientific Corporation	8
Micro-Tech (Nanjing) Co., Ltd.	8
Ovesco Endoscopy AG	8
Hangzhou AGS MedTech Co., Ltd.	6
Olympus Medical Systems Corp.	4
STERIS Corporation	4
Wilson-Cook Medical Inc.	4
Finemedix	2
Zhejiang Chuangxiang Medical Technology Co., Ltd.	2
Alton Shanghai Medical Instruments Co Ltd	1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 49 companies shown, in name order