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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
DateFirm and productCodeLinked 510(k)
Apr 13, 2026Wilson-Cook Medical Inc.
Instinct Plus Endoscopic Clipping Device REF: G58010 Rx Only, Sterile EO
Open, Classified		 PKLK212323
Jun 21, 2023Olympus Corporation of the Americas
Single Use Repositionable Clip QUICKCLIP PRO 230CM 5/BX- Intended for hemostatic metal clip for the GI Tract Catalog Number: HX-202UR.B
Open, Classified		 PKLK123601
Jun 21, 2023Olympus Corporation of the Americas
Single Use Repositionable Clip QUICKCLIP PRO 230 CM 10/BX- Intended for hemostatic metal clip for the GI Tract Catalog Number: HX-202UR.A
Open, Classified		 PKLK123601
Jun 21, 2023Olympus Corporation of the Americas
Single Use Repositionable Clip QUICKCLIP PRO 165CM 5/BX- Intended for hemostatic metal clip for the GI Tract Catalog Number: HX-202LR.B
Open, Classified		 PKLK123601
Jun 21, 2023Olympus Corporation of the Americas
Single Use Repositionable Clip QUICKCLIP PRO 165 CM 10/BX- Intended for hemostatic metal clip for the GI Tract Catalog Number: HX-202LR.A
Open, Classified		 PKLK123601
Feb 4, 2019US Endoscopy Group Inc
US Endoscopy Padlock Clip defect closure system Ref: C910001 The Padlock Clip is indicated for use in flexible endoscopy and for the compression of tissue in the gastrointestinal tract, for hemostas
Terminated		 PKLK120814

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