ClearanceBrief
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

Decided510(k)Device and applicantCode
Jan 6, 2017K161463SureClip(TM) Repositionable Hemostasis Clip
Micro-Tech (Nanjing) Co., Ltd., CN
PKL
Oct 12, 2016K153550FTRD System Set
Ovesco Endoscopy AG, DE
PKL
Dec 10, 2015K152001Sterile Repositionable Hemostasis Clipping Device
Micro-Tech (Nanjing) Co., Ltd., CN
PKL
Sep 16, 2015K150067OTSC Proctology
Ovesco Endoscopy AG, DE
PKL
Aug 6, 2015K151802Resolution Clip
Boston Scientific Corporation
PKL
Dec 1, 2014K142973Resolution Clip
Boston Scientific Corporation
PKL
Oct 25, 2013K132809INSTINCT ENDOSCOPIC HEMOCLIP
Wilson-Cook Medical, Inc.
PKL
Apr 29, 2013K123601SINGLE USE REPOSITIONABLE CLIP
Olympus Medical Systems Corp.
PKL
Dec 3, 2012K122660RESOLUTION CLIP MODEL M00522600, M00522601, M00522602, M00522610, M00522611, M00522612
Boston Scientific Corporation
PKL
Sep 6, 2012K120814PADLOCK CLIP-12
Aponos Medical Corp.
PKL
Aug 31, 2012K121505DISPOSABLE HEMOSTASIS CHIP
Wilson-Cook Medical Inc./Cook Endoscopy
PKL
Dec 22, 2010K102764RESOLUTION II CLIP
Boston Scientific Corporation
PKL
Dec 1, 2010K101428OTSC (OVER-THE SCOPE-CLIP) SYSTEM SET
Ovesco Endoscopy AG, DE
PKL
Feb 20, 2003K023903WILSON-COOK ENDOSCOPIC CLIPPING DEVICE
Wilson-Cook Medical, Inc.
PKL
Feb 7, 2002K013889ENDOSCOPIC MULTI-FIRE CLIP APPLIER
Inscope, LLC
PKL
Mar 26, 1999K990687HX-5/6-1 ENDOSCOPIC CLIPPING DEVICE, ENDOSCOPIC CLIPS
Olympus Optical, Co.
PKL
Jun 27, 1997K963160HX-5/6-1 ENDOSCOPIC CLIPPING DEVICE
Olympus America, Inc.
PKL

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