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

Colonoscope And Accessories, Flexible/Rigid

Regulation 876.1500

5510(k)s in 12 months (115 all time)
0recalls in 12 months (25 all time)
25recalls that name a 510(k)
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Top companies in FDF

Company510(k)sRecalls
Pentax Precision Instrument Corp.110
Aizu Olympus Co., Ltd.16
Motus GI Medical Technologies , Ltd.70
Olympus Medical Systems Corp.70
Olympus Corporation of the Americas07
Pentax of America, Inc.25
Avantis Medical Systems, Inc.60
Lumendi, LLC60
Fujifilm Corporation50
Fujifilm Medical Systems U.S.A, Inc.50
Decided510(k)Device and applicantCode
Feb 23, 2016K160196Fujifilm Video Colonoscope Model EC-600WL V2
Fujifilm Medical Systems U.S.A, Inc.
FDF
Dec 15, 2015K153483Balloon controller PB-30
Fujifilm Medical Systems U.S.A, Inc.
FDF
Jul 6, 2015K143732FUJIFILM Endoscope Models EC-600HL and EC-600LS
Fujifilm Medical Systems U.S.A, Inc.
FDF
Nov 17, 2014K140595THIRD EYE PANORAMIC AUXILIARY ENDOSCOPY SYSTEM
Avantis Medical Systems, Inc.
FDF
Sep 30, 2014K141598FUSE COLONOSCOPY SYSTEM
Endochoice, Inc., IL
FDF
Sep 30, 2014K141286AER-O-SCOPE COLONOSCOPE SYSTEM
Gi View , Ltd.
FDF
Apr 9, 2014K131855PENTAX VIDEO COLONOSCOPES (EC FAMILY)
Pentax Medical Company
FDF
Feb 6, 2014K132839FUSE 1C COLONOSCOPY SYSTEM
Endochoice, Inc.
FDF
Jan 10, 2014K132210FUJIFILM 600 SERIES ENDOSCOPES
Fujifilm Medical Systems U.S.A, Inc.
FDF
Aug 29, 2013K131780EVIS EXERA III VIDEO SYSTEM
Olympus Medical Systems Corp.
FDF
Apr 16, 2013K130718PEERSCOPE SYSTEM
Peermedical , Ltd., IL
FDF
Dec 20, 2012K121582INVENDO C25 COLONOSCOPY SYSTEM
Invendo Medical Gbmh, DE
FDF
Sep 28, 2012K120289PEERSCOPE SYSTEM
Peermedical, IL
FDF
Jul 26, 2012K112391FUJINON COLONOSCOPES
Fujinon, Inc.
FDF
May 16, 2012K113050CLEARPATH LOWER GI
Easyglide , Ltd.
FDF
Mar 20, 2012K111756V1 SYSTEM
Olympus Medical Systems Corp.
FDF
Feb 23, 2012K100624INVENDO C20 COLONOSCOPY SYSTEM
Invendo Medical Gbmh, DE
FDF
Feb 16, 2012K112680EVIS EXERA III VIDEO SYSTEM
Olympus Medical Systems Corporation
FDF
Nov 1, 2011K111028EUS BALLOON
United States Endoscopy Group, Inc.
FDF
May 12, 2011K103312UPD-Y0003
Olympus Medical Systems Corporation
FDF
Dec 30, 2010K102616NAVIAID BALLOON GUIDED COLONOSCOPY (BGC) DEVICE
Smart Medical Systems , Ltd., IL
FDF
Aug 3, 2010K100966COLONOSCOPE/SIGMOIDOSCOPE SHEATHES
Sheathing Technologies, Inc.
FDF
Jul 27, 2010K101191NAVIAID ICVI DEVICE
Smart Medical Systems , Ltd., IL
FDF
Jul 14, 2010K101053OLYMPUS CF TYPE Y0023-L, Y0023I
Olympus Medical Systems Corporation
FDF
Dec 28, 2009K093037PENTEX EC-3890LI
Pentax Medical Company
FDF
Nov 5, 2009K093187MODIFICATION TO THIRD EYE RETROSCOPE AUXILIARY ENDOSCOPY SYSTEM
Avantis Medical Systems, Inc.
FDF
Oct 23, 2009K091305CLEARPATH
Easyglide , Ltd.
FDF
Jul 7, 2009K091783THIRD EYE RETROSCOPE AUXILIARY ENDOSCOPE SYSTEM
Avantis Medical Systems, Inc.
FDF
Apr 22, 2009K090116FUJINON COLONOSCOPE FOR DOUBLE BALLOON ENTERSCOPY SYSTEM MODEL, EC-450B15
Fujinon, Inc., JP
FDF
Feb 12, 2009K083180THIRD EYE RETROSCOPE AUXILIARY ENDOSCOPY SYSTEM
Avantis Medical Systems, Inc.
FDF
May 2, 2008K081004PROTECTISCOPE CS COLONOSCOPE, NON-INTRAPULL
Stryker GI
FDF
Apr 29, 2008K080317ENOLOK-FOR ENDOSCOPED WITH 12.8>DIA.<13.3MM SHAFT DIAMETER, MODEL AEL; ENDOSCOPES WITH 11.3>DIA. 11.5MM SHAFT ,MODEL PEL
Syntheon, LLC
FDF
Aug 14, 2007K070622NEOGUIDE ENDOSCOPY SYSTEM
Neoguide Systems, Inc.
FDF
Apr 24, 2007K070330THIRD EYE RETROSCOPE AUXILIARY ENDOSCOPY SYSTEM
Avantis Medical Systems, Inc.
FDF
Jan 31, 2007K063654ENDOGUIDE
Kms Medical, LLC
FDF
Jan 31, 2007K063585KARL STORZ VIDEO LOWER G.I. ENDOSCOPE SYSTEM
KARL STORZ Endoscopy-America, Inc.
FDF
Jan 31, 2006K052930NAVIGATOR ENDOSCOPY SYSTEM
Neoguide Systems, Inc.
FDF
Jul 11, 2005K051068ZUTRON COLONOSCOPE STIFFENING DEVICE
Zutron Medical
FDF
Jul 1, 2005K051541GF-UE160-AL5 ULTRASOUND ENDOSCOPE
Olympus America, Inc.
FDF
Jan 28, 2005K043487EVIS EXERA COLONOVIDEOSCOPE MODEL XCF-Q160W1L/1
Aizu Olympus Co., Ltd.
FDF
Nov 10, 2004K041903FUJINON G5 COLONOSCOPES, MODELS EC-450HL5 AND EC-250HL5
Fujinon, Inc.
FDF
Mar 5, 2004K032688COLONOSIGHT MODEL 510B
Sightline Technologies , Ltd., IL
FDF
Dec 26, 2002K023259INHEALTH SOFT SLEEVE COLONOSCOPE SPLINT, MODEL CS1200
Helix Medical, Inc.
FDF
Dec 4, 2000K002749ENDOSCOPE CONTOUR DETECTION DEVICE, MODEL 3DX45 AND COLONOSCOPE, MODEL XCF-Q140L/13D
The Olympus Optical Co.
FDF
May 9, 2000K001241EVIS EXERA COLONOVIDEOSCOPE CF-Q160 AL/I AND PCF-160 AL/I
The Olympus Optical Co.
FDF
Mar 11, 1997K970372GASTROSCOPE AND COLONOSCOPE NOZZLE REPLACEMENT KITS
Precision Endoscopy of America, Inc.
FDF
Jun 24, 1996K961570KEC-3840L/F, VIDEO COLONOSCOPE (*L OR F IN MODEL NUMBER DENOTES LENGTH)
Pentax Precision Instrument Corp.
FDF
Jun 19, 1996K961563EC-384OTL, VIDEO COLONSCOPE
Pentax Precision Instrument Corp.
FDF
Mar 21, 1996K951579EC-3800TL, VIDEO COLONOSCOPE
Pentax Precision Instrument Corp.
FDF
Mar 21, 1996K951574EC-3800L, VIDEO COLONOSCOPE
Pentax Precision Instrument Corp.
FDF

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