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Panels › Gastroenterology, Urology › Product code PKL · Class 2

Hemostatic Metal Clip For The Gi Tract

Regulation 876.4400

9510(k)s in 12 months (67 all time)
1recalls in 12 months (6 all time)
6recalls that name a 510(k)
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Top companies in PKL

Company510(k)sRecalls
Ovesco Endoscopy AG100
Boston Scientific Corporation80
Micro-Tech (Nanjing) Co., Ltd.80
Hangzhou AGS MedTech Co., Ltd.60
Olympus Medical Systems Corp.40
Olympus Corporation of the Americas04
STERIS Corporation40
Wilson-Cook Medical, Inc.31
Finemedix Co., Ltd.20
Zhejiang Chuangxiang Medical Technology Co., Ltd.20
Decided510(k)Device and applicantCode
Oct 2, 2026K261741Hemostatic Clip
Anrei Medical (Hz) Co., Ltd., CN
PKL
Oct 2, 2026K260487stentFIX System Set (100.50n)
Ovesco Endoscopy AG, DE
PKL
Sep 14, 2026K253481colonic FTRD Set (200.70); diagnostic FTRD Set (200.76); gastroduodenal FTRD Set (200.72)
Ovesco Endoscopy AG, DE
PKL
Aug 10, 2026K254069Hemoclip (511 series, 543 series)
Hangzhou AGS MedTech Co., Ltd., CN
PKL
May 21, 2026K260580Single Use Reloadable Clip Applicator (HX-810LR, HX-810UR); Clip (HX-610-090, HX-610-135); Long Clip (HX-610-090L, HX-61
Olympus Medical Systems Corp., JP
PKL
Apr 8, 2026K252270Hemoclip
Hangzhou AGS MedTech Co., Ltd., CN
PKL
Mar 12, 2026K253734Taurus Clip
Taurus Endoscopy, FR
PKL
Dec 18, 2025K251562OTSCneo System Set (100.03n-14n, 100.27n-31n)
Ovesco Endoscopy AG, DE
PKL
Nov 12, 2025K252271Hemoclip
Hangzhou AGS MedTech Co., Ltd., CN
PKL
Sep 8, 2025K250229Dual Action Tissue Closure Device
Micro-Tech (Nanjing) Co., Ltd., CN
PKL
Apr 18, 2025K250842PADLOCK CLIP EFTR Kit (00713229)
STERIS Corporation
PKL
Feb 6, 2025K250066Resolution Clip (M00522600); Resolution Clip (M00522601); Resolution Clip (M00522602); Resolution Clip (M00522610); Reso
Boston Scientific Corporation
PKL
Jan 2, 2025K241005Haemostasis Clips
Jiangxi Zhuoruihua Medical Instrument Co., Ltd., CN
PKL
Sep 17, 2024K240274PADLOCK CLIP EFTR Kit (00713229)
STERIS Corporation
PKL
Aug 26, 2024K241858BARS Set (100.60)
Ovesco Endoscopy AG, DE
PKL
Jul 12, 2024K234124Single Use Hemoclips
Promisemed Hangzhou Meditech Co., Ltd., CN
PKL
Jun 7, 2024K232969Disposable Hemostatic Clips
Ningbo Xinwell Medical Technology Co., Ltd., CN
PKL
Jun 3, 2024K240617Single Use Reloadable Clip Applicator (HX-810LR, HX-810UR); Clip (HX-610-090, HX-610-135); Long Clip (HX-610-090L, HX-61
Olympus Medical Systems Corp., JP
PKL
Mar 19, 2024K233772Disposable Dual Action Tissue Closure Device
Mirco-Tech (Nanjing) Co., Ltd., CN
PKL
Jan 26, 2024K232450Disposable Hemostatic Clips
Zhejiang Soudon Medical Technology Co., Ltd., CN
PKL
Jan 11, 2024K231633Disposable Hemoclip (AF series)
Alton (Shanghai) Medical Instruments Co., Ltd., CN
PKL
Jul 31, 2023K230004Disposable Hemoclip
Yangzhou Fartley Medical Instrument Technology Co., Ltd., CN
PKL
Mar 28, 2023K222146Disposable Endoscopic Hemoclip
Jiangsu Vedkang Medical Science and Technology Co., Ltd., CN
PKL
Nov 14, 2022K213217Disposable hemoclip
Beijing Zksk Technology Co., Ltd., CN
PKL
Sep 14, 2022K222503Resolution Clip, Resolution 360 Clip, Resolution 360 ULTRA Clip
Boston Scientific Corporation
PKL
Aug 4, 2022K221124MANTIS Clip
Boston Scientific Corporation
PKL
Jul 12, 2022K213143Hemoclip
Hangzhou AGS MedTech Co., Ltd., CN
PKL
Jun 23, 2022K213338CORE-CLIP
Incore Co., Ltd., KR
PKL
Jun 13, 2022K220157Disposable Hemostatic Closure Clip Device
Micro-Tech (Nanjing) Co., Ltd., CN
PKL
May 27, 2022K212669Single Use Hemoclip
Zhejiang Chuangxiang Medical Technology Co., Ltd., CN
PKL
Mar 3, 2022K211787Hemoclip
Hangzhou AGS MedTech Co., Ltd., CN
PKL
Jan 20, 2022K212748Disposable Dual Action Tissue Clip
Micro-Tech (Nanjing) Co., Ltd., CN
PKL
Aug 25, 2021K212323Instinct Plus Endoscopic Clipping Device
Wilson-Cook Medical, Inc.
PKL
Jan 14, 2021K202333Lockado Repositionable Hemostasis Clip
Micro-Tech (Nanjing) Co., Ltd., CN
PKL
Dec 15, 2020K201808X-Tack Endoscopic HeliX Tacking System
Apollo Endosurgery, Inc.
PKL
Oct 19, 2020K201771Single Use Rotatable and Repositionable Hemoclip
Anrei Medical (Hangzhou) Co., Ltd., CN
PKL
Oct 5, 2020K200217ClearEndoclip
Finemedix Co., Ltd., KR
PKL
Sep 1, 2020K193424Resolution 360™ ULTRA Clip
Boston Scientific Corporation
PKL
Jun 2, 2020K200684gastroduodenal FTRD Set
Ovesco Endoscopy AG, DE
PKL
Mar 5, 2020K192697Instinct Plus Endoscopic Clipping Device
Cook Endoscopy
PKL
Oct 24, 2019K192722Padlock Clip defect closure system, Padlock Pro-Select defect closure device
STERIS Corporation
PKL
Oct 22, 2019K183309stentfix OTSC System Set
Ovesco Endoscopy AG, DE
PKL
Aug 1, 2019K183590Single Use Reloadable Clip Applicator, Clip, Long Clip, Short Clip, Super Short Clip
Olympus Medical Systems Corp., JP
PKL
Jun 28, 2019K183021ClearEndoclip
Finemedix Co., Ltd., KR
PKL
Dec 14, 2018K182556SureClip Repositionable Hemostasis Clip
Micro-Tech (Nanjing) Co., Ltd., CN
PKL
Jun 1, 2018K180325Single Use MultiClip Device
Micro-Tech (Nanjing) Co., Ltd., CN
PKL
Apr 16, 2018K172727Hemoclip
Hangzhou AGS MedTech Co., Ltd., CN
PKL
Apr 12, 2018K180689Padlock Clip defect closure device; Padlock Clip Pro-Select defect closure device
STERIS Corporation
PKL
Mar 20, 2018K172762Single Use Hemoclip
Zhejiang Chuangxiang Medical Technology Co., Ltd., CN
PKL
Jul 25, 2017K170867FTRD System Set
Ovesco Endoscopy AG, DE
PKL

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