Atlas FDA

PKL

63 FDA 510(k) clearances · Product code

159 daysmedian time to decision
267 days90th percentile
63clearances measured

FDA profile

Official device name
Hemostatic Metal Clip For The Gi Tract
Device class
Class II (moderate risk)
Regulation
21 CFR 876.4400
Medical specialty
Gastroenterology, Urology
Flags
Implant · Life-sustaining
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.
Adverse events (MAUDE)
2021: 668 · 2022: 522 · 2023: 863 · 2024: 1,216 · 2025: 1,191 · 2026: 525
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
Single Use Reloadable Clip Applicator (HX-810LR, HX-810UR); Clip (HX-610-090, HX-610-135); Long Clip (HX-610-090L, HX-610-135L); Short Clip (HX-610-090S, HX-610-135S); Super Short Clip (HX-610-135XS) (K260580)Olympus Medical Systems Corp.2026-05-21
Hemoclip (K252270)Hangzhou AGS MedTech Co., Ltd.2026-04-08
Taurus Clip (K253734)Taurus Endoscopy2026-03-12
OTSCneo System Set (100.03n-14n, 100.27n-31n) (K251562)Ovesco Endoscopy AG2025-12-18
Hemoclip (K252271)Hangzhou AGS MedTech Co., Ltd.2025-11-12
Dual Action Tissue Closure Device (K250229)Micro-Tech (Nanjing) Co., Ltd.2025-09-08
PADLOCK CLIP EFTR Kit (00713229) (K250842)STERIS Corporation2025-04-18
Resolution Clip (M00522600); Resolution Clip (M00522601); Resolution Clip (M00522602); Resolution Clip (M00522610); Resolution Clip (M00522611); Resolution Clip (M00522612) (K250066)Boston Scientific Corporation2025-02-06
Haemostasis Clips (K241005)Jiangxi Zhuoruihua Medical Instrument Co., Ltd.2025-01-02
PADLOCK CLIP EFTR Kit (00713229) (K240274)STERIS Corporation2024-09-17
BARS Set (100.60) (K241858)Ovesco Endoscopy AG2024-08-26
Single Use Hemoclips (K234124)Promisemed Hangzhou Meditech Co., Ltd.2024-07-12
Disposable Hemostatic Clips (K232969)Ningbo Xinwell Medical Technology Co., Ltd.2024-06-07
Single Use Reloadable Clip Applicator (HX-810LR, HX-810UR); Clip (HX-610-090, HX-610-135); Long Clip (HX-610-090L, HX-610-135L); Short Clip (HX-610-090S, HX-610-135S); Super Short Clip (HX-610-135XS) (K240617)Olympus Medical Systems Corp.2024-06-03
Disposable Dual Action Tissue Closure Device (K233772)Mirco-Tech (Nanjing) Co., Ltd.2024-03-19
Disposable Hemostatic Clips (K232450)Zhejiang Soudon Medical Technology Co., Ltd.2024-01-26
Disposable Hemoclip (AF series) (K231633)Alton (Shanghai) Medical Instruments Co., Ltd.2024-01-11
Disposable Hemoclip (K230004)Yangzhou Fartley Medical Instrument Technology Co., Ltd.2023-07-31
Disposable Endoscopic Hemoclip (K222146)Jiangsu Vedkang Medical Science and Technology Co., Ltd.2023-03-28
Disposable hemoclip (K213217)Beijing Zksk Technology Co., Ltd.2022-11-14
Resolution Clip, Resolution 360 Clip, Resolution 360 ULTRA Clip (K222503)Boston Scientific Corporation2022-09-14
MANTIS Clip (K221124)Boston Scientific Corporation2022-08-04
Hemoclip (K213143)Hangzhou AGS MedTech Co., Ltd.2022-07-12
CORE-CLIP (K213338)Incore Co., Ltd.2022-06-23
Disposable Hemostatic Closure Clip Device (K220157)Micro-Tech (Nanjing) Co., Ltd.2022-06-13
Single Use Hemoclip (K212669)Zhejiang Chuangxiang Medical Technology Co., Ltd.2022-05-27
Hemoclip (K211787)Hangzhou AGS MedTech Co., Ltd.2022-03-03
Disposable Dual Action Tissue Clip (K212748)Micro-Tech (Nanjing) Co., Ltd.2022-01-20
Instinct Plus Endoscopic Clipping Device (K212323)Wilson-Cook Medical, Inc.2021-08-25
Lockado Repositionable Hemostasis Clip (K202333)Micro-Tech (Nanjing) Co., Ltd.2021-01-14
X-Tack Endoscopic HeliX Tacking System (K201808)Apollo Endosurgery, Inc.2020-12-15
Single Use Rotatable and Repositionable Hemoclip (K201771)Anrei Medical (Hangzhou) Co., Ltd.2020-10-19
ClearEndoclip (K200217)Finemedix Co., Ltd.2020-10-05
Resolution 360™ ULTRA Clip (K193424)Boston Scientific Corporation2020-09-01
gastroduodenal FTRD Set (K200684)Ovesco Endoscopy AG2020-06-02
Instinct Plus Endoscopic Clipping Device (K192697)Cook Endoscopy2020-03-05
Padlock Clip defect closure system, Padlock Pro-Select defect closure device (K192722)STERIS Corporation2019-10-24
stentfix OTSC System Set (K183309)Ovesco Endoscopy AG2019-10-22
Single Use Reloadable Clip Applicator, Clip, Long Clip, Short Clip, Super Short Clip (K183590)Olympus Medical Systems Corp.2019-08-01
ClearEndoclip (K183021)Finemedix Co., Ltd.2019-06-28
SureClip Repositionable Hemostasis Clip (K182556)Micro-Tech (Nanjing) Co., Ltd.2018-12-14
Single Use MultiClip Device (K180325)Micro-Tech (Nanjing) Co., Ltd.2018-06-01
Hemoclip (K172727)Hangzhou AGS MedTech Co., Ltd.2018-04-16
Padlock Clip defect closure device; Padlock Clip Pro-Select defect closure device (K180689)STERIS Corporation2018-04-12
Single Use Hemoclip (K172762)Zhejiang Chuangxiang Medical Technology Co., Ltd.2018-03-20
FTRD System Set (K170867)Ovesco Endoscopy AG2017-07-25
SureClip(TM) Repositionable Hemostasis Clip (K161463)Micro-Tech (Nanjing) Co., Ltd.2017-01-06
FTRD System Set (K153550)Ovesco Endoscopy AG2016-10-12
Sterile Repositionable Hemostasis Clipping Device (K152001)Micro-Tech (Nanjing) Co., Ltd.2015-12-10
OTSC Proctology (K150067)Ovesco Endoscopy AG2015-09-16
Resolution Clip (K151802)Boston Scientific Corporation2015-08-06
Resolution Clip (K142973)Boston Scientific Corporation2014-12-01
INSTINCT ENDOSCOPIC HEMOCLIP (K132809)Wilson-Cook Medical, Inc.2013-10-25
SINGLE USE REPOSITIONABLE CLIP (K123601)Olympus Medical Systems Corp.2013-04-29
RESOLUTION CLIP MODEL M00522600, M00522601, M00522602, M00522610, M00522611, M00522612 (K122660)Boston Scientific Corporation2012-12-03
PADLOCK CLIP-12 (K120814)Aponos Medical Corp.2012-09-06
DISPOSABLE HEMOSTASIS CHIP (K121505)Wilson-Cook Medical Inc./Cook Endoscopy2012-08-31
RESOLUTION II CLIP (K102764)Boston Scientific Corporation2010-12-22
OTSC (OVER-THE SCOPE-CLIP) SYSTEM SET (K101428)Ovesco Endoscopy AG2010-12-01
WILSON-COOK ENDOSCOPIC CLIPPING DEVICE (K023903)Wilson-Cook Medical, Inc.2003-02-20
ENDOSCOPIC MULTI-FIRE CLIP APPLIER (K013889)Inscope, LLC2002-02-07
HX-5/6-1 ENDOSCOPIC CLIPPING DEVICE, ENDOSCOPIC CLIPS (K990687)Olympus Optical, Co.1999-03-26
HX-5/6-1 ENDOSCOPIC CLIPPING DEVICE (K963160)Olympus America, Inc.1997-06-27

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Every clearance here is in the API, with alerts when new ones post.