FDA 510(k) Applications for Medical Device Product Code "FDF"
(Colonoscope And Accessories, Flexible/Rigid)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K043487 | AIZU OLYMPUS CO., LTD. | EVIS EXERA COLONOVIDEOSCOPE MODEL XCF-Q160W1L/1 | 01/28/2005 |
| K230332 | Ambu A/S | Ambu« aScopeÖ Colon; Ambu« aBoxÖ 2 | 09/15/2023 |
| K093187 | AVANTIS MEDICAL SYSTEMS, INC. | MODIFICATION TO THIRD EYE RETROSCOPE AUXILIARY ENDOSCOPY SYSTEM | 11/05/2009 |
| K140595 | AVANTIS MEDICAL SYSTEMS, INC. | THIRD EYE PANORAMIC AUXILIARY ENDOSCOPY SYSTEM | 11/17/2014 |
| K160356 | AVANTIS MEDICAL SYSTEMS, INC. | Third Eye Panoramic Auxiliary Endoscopy System - Resposable | 05/17/2016 |
| K091783 | AVANTIS MEDICAL SYSTEMS, INC. | THIRD EYE RETROSCOPE AUXILIARY ENDOSCOPE SYSTEM | 07/07/2009 |
| K070330 | AVANTIS MEDICAL SYSTEMS, INC. | THIRD EYE RETROSCOPE AUXILIARY ENDOSCOPY SYSTEM | 04/24/2007 |
| K083180 | AVANTIS MEDICAL SYSTEMS, INC. | THIRD EYE RETROSCOPE AUXILIARY ENDOSCOPY SYSTEM | 02/12/2009 |
| K213773 | Bpendo, LLC | Insufflation Retention Device | 07/21/2022 |
| K091305 | EASYGLIDE LTD. | CLEARPATH | 10/23/2009 |
| K113050 | EASYGLIDE LTD. | CLEARPATH LOWER GI | 05/16/2012 |
| K132839 | ENDOCHOICE, INC. | FUSE 1C COLONOSCOPY SYSTEM | 02/06/2014 |
| K141598 | ENDOCHOICE, INC. | FUSE COLONOSCOPY SYSTEM | 09/30/2014 |
| K190669 | Era Endoscopy s.r.l. | Endotics | 01/03/2020 |
| K223827 | FUJIFILM Corporation | FUJIFILM Endoscope Model EC-760S-A/L, Endoscopy Support Program EW10-VM01 | 09/08/2023 |
| K190649 | FUJIFILM Corporation | FUJIFILM Endoscope Model EC-760S-V/L | 05/07/2019 |
| K192664 | FUJIFILM Corporation | FUJIFILM Endoscope Model EC-760Z-V/L | 11/20/2019 |
| K180405 | FUJIFILM Corporation | FUJIFILM Endoscope Models EC-600HL and EC-600LS | 03/15/2018 |
| K153483 | FUJIFILM MEDICAL SYSTEMS U.S.A., INC. | Balloon controller PB-30 | 12/15/2015 |
| K132210 | FUJIFILM MEDICAL SYSTEMS U.S.A., INC. | FUJIFILM 600 SERIES ENDOSCOPES | 01/10/2014 |
| K143732 | FUJIFILM Medical Systems U.S.A., Inc. | FUJIFILM Endoscope Models EC-600HL and EC-600LS | 07/06/2015 |
| K162622 | FUJIFILM Medical Systems U.S.A., Inc. | Fujifilm Endoscope Models EC-600HL and EC-600LS | 10/18/2016 |
| K160196 | FUJIFILM Medical Systems U.S.A., Inc. | Fujifilm Video Colonoscope Model EC-600WL V2 | 02/23/2016 |
| K090116 | FUJINON, INC. | FUJINON COLONOSCOPE FOR DOUBLE BALLOON ENTERSCOPY SYSTEM MODEL, EC-450B15 | 04/22/2009 |
| K112391 | FUJINON, INC. | FUJINON COLONOSCOPES | 07/26/2012 |
| K041903 | FUJINON, INC. | FUJINON G5 COLONOSCOPES, MODELS EC-450HL5 AND EC-250HL5 | 11/10/2004 |
| K171673 | GCE Medical Corporation | Focus Cap | 01/19/2018 |
| K161791 | GI View Ltd. | Aer-O-Scope Colonoscope System | 08/11/2016 |
| K230588 | GI View Ltd. | Aer-O-Scope Colonoscope System | 08/17/2023 |
| K141286 | GI VIEW LTD. | AER-O-SCOPE COLONOSCOPE SYSTEM | 09/30/2014 |
| K213578 | Hangzhou AGS MedTech Co., Ltd. | Balloon Dilatation Catheter | 04/06/2022 |
| K023259 | HELIX MEDICAL, INC. | INHEALTH SOFT SLEEVE COLONOSCOPE SPLINT, MODEL CS1200 | 12/26/2002 |
| K100624 | INVENDO MEDICAL GBMH | INVENDO C20 COLONOSCOPY SYSTEM | 02/23/2012 |
| K121582 | INVENDO MEDICAL GBMH | INVENDO C25 COLONOSCOPY SYSTEM | 12/20/2012 |
| K161355 | Invendo Medical GmbH | invendoscopy E200 System | 08/25/2016 |
| K173085 | invendo medical GmbH | invendoscopy E210 System | 01/08/2018 |
| K063585 | KARL STORZ ENDOSCOPY-AMERICA, INC. | KARL STORZ VIDEO LOWER G.I. ENDOSCOPE SYSTEM | 01/31/2007 |
| K063654 | KMS MEDICAL LLC | ENDOGUIDE | 01/31/2007 |
| K221452 | Lumendi, LLC | DiLumen C1, EZ1 and Tool Mount | 02/10/2023 |
| K211819 | Lumendi, LLC | DiLumen C2 and Tool Mount | 10/22/2021 |
| K173317 | Lumendi, LLC | DiLumen C2; DiLumen Tool Mount | 04/17/2018 |
| K162428 | Lumendi, LLC | DiLumen Endolumenal Interventional Platform | 12/06/2016 |
| K182540 | Lumendi, LLC | DiLumen Endolumenal Interventional Platform | 10/30/2018 |
| K210851 | Lumendi, LLC | DiLumen Endolumenal Interventional Platform (DiLumen) | 04/21/2021 |
| K162330 | Medrobotics Corporation | Flex Robotic System and Flex Colorectal Drive | 05/04/2017 |
| K172036 | Medrobotics Corporation | Medrobotics Flex Robotic System | 08/03/2017 |
| K160015 | Motus GI Medical Technologies Ltd. | Pure Vu | 09/22/2016 |
| K181437 | Motus GI Medical Technologies Ltd. | Pure Vu System | 06/21/2018 |
| K191220 | Motus GI Medical Technologies Ltd. | Pure Vu System | 06/06/2019 |
| K210981 | Motus GI Medical Technologies Ltd. | Pure Vu System | 04/29/2021 |
| K220007 | Motus GI Medical Technologies Ltd. | Pure-Vu EVS System | 02/10/2022 |
| K173392 | Motus GI Medical Technologies Ltd. | Pure-Vu System | 12/12/2017 |
| K052930 | NEOGUIDE SYSTEMS, INC. | NAVIGATOR ENDOSCOPY SYSTEM | 01/31/2006 |
| K070622 | NEOGUIDE SYSTEMS, INC. | NEOGUIDE ENDOSCOPY SYSTEM | 08/14/2007 |
| K051541 | OLYMPUS AMERICA, INC. | GF-UE160-AL5 ULTRASOUND ENDOSCOPE | 07/01/2005 |
| K192793 | Olympus Medical Systems Corp. | Evis Exera III Colonovideoscope Olympus PCF-H190TL, Evis Exera III Colonovideoscope Olympus PCF-H190TI, Evis Exera III Colonovideoscope Olympus PCF-HQ190L, Evis Exera III Colonovideoscope Olympus PCF-HQ190I | 07/17/2020 |
| K131780 | OLYMPUS MEDICAL SYSTEMS CORP. | EVIS EXERA III VIDEO SYSTEM | 08/29/2013 |
| K111756 | OLYMPUS MEDICAL SYSTEMS CORP. | V1 SYSTEM | 03/20/2012 |
| K112680 | OLYMPUS MEDICAL SYSTEMS CORPORATION | EVIS EXERA III VIDEO SYSTEM | 02/16/2012 |
| K101053 | OLYMPUS MEDICAL SYSTEMS CORPORATION | OLYMPUS CF TYPE Y0023-L, Y0023I | 07/14/2010 |
| K103312 | OLYMPUS MEDICAL SYSTEMS CORPORATION | UPD-Y0003 | 05/12/2011 |
| K120289 | PEERMEDICAL | PEERSCOPE SYSTEM | 09/28/2012 |
| K130718 | PEERMEDICAL LTD. | PEERSCOPE SYSTEM | 04/16/2013 |
| K131855 | PENTAX MEDICAL COMPANY | PENTAX VIDEO COLONOSCOPES (EC FAMILY) | 04/09/2014 |
| K093037 | PENTAX MEDICAL COMPANY | PENTEX EC-3890LI | 12/28/2009 |
| K180285 | PENTAX Medical of America, Inc | PENTAX Medical Video Colonoscope EC34-i10T Series | 10/26/2018 |
| K181084 | PENTAX of America, Inc. | PENTAX Video Colonoscopes (EC Family) | 01/18/2019 |
| K951574 | PENTAX PRECISION INSTRUMENT CORP. | EC-3800L, VIDEO COLONOSCOPE | 03/21/1996 |
| K951579 | PENTAX PRECISION INSTRUMENT CORP. | EC-3800TL, VIDEO COLONOSCOPE | 03/21/1996 |
| K961563 | PENTAX PRECISION INSTRUMENT CORP. | EC-384OTL, VIDEO COLONSCOPE | 06/19/1996 |
| K961570 | PENTAX PRECISION INSTRUMENT CORP. | KEC-3840L/F, VIDEO COLONOSCOPE (*L OR F IN MODEL NUMBER DENOTES LENGTH) | 06/24/1996 |
| K970372 | PRECISION ENDOSCOPY OF AMERICA, INC. | GASTROSCOPE AND COLONOSCOPE NOZZLE REPLACEMENT KITS | 03/11/1997 |
| K210052 | Saneso Inc. | Saneso Colonoscope 360-A (Model: with/without Select Band Imaging (SBI) and with/without Dual Band Imaging(DBI)), Saneso Single Camera Colonoscope-A (Model: with/without Select Band Imaging (SBI)), Saneso Gastroscope 360-A (Model: with/without Select Band | 04/01/2022 |
| K100966 | SHEATHING TECHNOLOGIES, INC. | COLONOSCOPE/SIGMOIDOSCOPE SHEATHES | 08/03/2010 |
| K032688 | SIGHTLINE TECHNOLOGIES LTD. | COLONOSIGHT MODEL 510B | 03/05/2004 |
| K220158 | Smart Medical Systems Ltd. | G-EYE System | 04/11/2022 |
| K192588 | SMART Medical Systems Ltd. | G-EYE System | 04/15/2020 |
| K202469 | SMART Medical Systems Ltd. | G-EYE System | 10/26/2020 |
| K102616 | SMART MEDICAL SYSTEMS, LTD. | NAVIAID BALLOON GUIDED COLONOSCOPY (BGC) DEVICE | 12/30/2010 |
| K101191 | SMART MEDICAL SYSTEMS, LTD. | NAVIAID ICVI DEVICE | 07/27/2010 |
| K081004 | STRYKER GI | PROTECTISCOPE CS COLONOSCOPE, NON-INTRAPULL | 05/02/2008 |
| K080317 | SYNTHEON LLC | ENOLOK-FOR ENDOSCOPED WITH 12.8>DIA.<13.3MM SHAFT DIAMETER, MODEL AEL; ENDOSCOPES WITH 11.3>DIA. 11.5MM SHAFT ,MODEL PEL | 04/29/2008 |
| K002749 | THE OLYMPUS OPTICAL CO. | ENDOSCOPE CONTOUR DETECTION DEVICE, MODEL 3DX45 AND COLONOSCOPE, MODEL XCF-Q140L/13D | 12/04/2000 |
| K001241 | THE OLYMPUS OPTICAL CO. | EVIS EXERA COLONOVIDEOSCOPE CF-Q160 AL/I AND PCF-160 AL/I | 05/09/2000 |
| K111028 | UNITED STATES ENDOSCOPY GROUP, INC. | EUS BALLOON | 11/01/2011 |
| K163492 | United states Endoscopy Group, Inc. | Oracle EUS Balloon; Oracle EUS latex balloon - Olympus Radial; Oracle EUS latex balloon - Olympus Linear; Oracle EUS latex balloon - Fujinon Radial; Oracle EUS latex balloon - Fujinon Linear | 01/06/2017 |
| K954704 | WELCH ALLYN, INC. | VS-200 VIDEO SIGMOIDOSCOPE | 03/07/1996 |
| K051068 | ZUTRON MEDICAL | ZUTRON COLONOSCOPE STIFFENING DEVICE | 07/11/2005 |
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