FDA 510(k) Applications for Medical Device Product Code "FDS"
(Gastroscope And Accessories, Flexible/Rigid)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K212382 | Ambu A/S | Ambu« aScopeÖ Gastro, Ambu« aBoxÖ2 | 02/03/2022 |
| K093779 | EASYGLIDE LTD. | CLEARPATH UGI | 03/09/2010 |
| K113166 | EASYGLIDE LTD. | CLEARPATH UPPER GI | 05/16/2012 |
| K152182 | ENDOCHOICE INC. | Fuse Gastroscopy System | 12/10/2015 |
| K131422 | ENDOCHOICE, INC. | PEERSCOPE SYSTEM | 10/10/2013 |
| K213606 | EvoEndo Inc | EvoEndo Single-Use Endoscopy System | 02/14/2022 |
| K974493 | FIEGERT-ENDOTECH MEDIZINTECHNIK GMBH | FIEGERT ENDOTECH FLEXIBLE FIBEROPTIC ENDOSCOPES, FIEGERT ENDOTECH FLEXIBLE VIDEO-ENDOSCOPES | 03/31/1998 |
| K212296 | FUJIFILM Corporation | Distal Cap Model DH-32EN, Distal Cap Model DH-17EN2 | 08/19/2021 |
| K210162 | FUJIFILM Corporation | Endoscope Model EI-740D/S | 04/09/2021 |
| K180341 | FUJIFILM Corporation | FUJIFILM 600 Series Endoscope EG-600WR v2 | 08/03/2018 |
| K193123 | FUJIFILM Corporation | FUJIFILM Distal Cap Models 33-40 | 12/11/2019 |
| K183686 | Fujifilm Corporation | FUJIFILM Endoscope Model EG-530N | 02/28/2019 |
| K182836 | FUJIFILM Corporation | FUJIFILM Endoscope Model EG-740N | 04/02/2019 |
| K183572 | FUJIFILM Corporation | FUJIFILM Endoscope Models EG-760CT, EC-760P-V/L and EC-740T/L | 07/16/2019 |
| K172916 | Fujifilm Corporation | FUJIFILM Endoscope Models EG-760R, EG-760Z, EC-760R-V/L and EC-760ZP-V/L, and FUJIFILM Water Tank Model WT-603 | 03/01/2018 |
| K181763 | FUJIFILM Corporation | FUJIFILM Ultrasonic Endoscope | 07/27/2018 |
| K200850 | FUJIFILM Corporation | Fujifilm Ultrasonic Processor | 07/06/2020 |
| K221551 | FUJIFILM Corporaton | FUJIFILM Endoscope Model EI-740D/S | 01/27/2023 |
| K232314 | Fujifilm Healthcare Americas Corporation | Hood (DH-106STL, DH-116STL, DH-126STL, DH-096ST) | 09/01/2023 |
| K142629 | FUJIFILM MEDICAL SYSTEM U.S.A., INC. | EG-530CT, EG-530D, EC-530DL, and ES-530WE Endoscopes | 05/14/2015 |
| K153206 | FUJIFILM MEDICAL SYSTEM U.S.A., INC. | Fujifilm Ultrasonic Processors SU-1 PLATINUM and SU-1 | 03/03/2016 |
| K162749 | FUJIFILM Medical Systems U.S.A., Inc. | FUJIFILM Hood Models DH-28GR, DH-29CR and DH-30CR | 06/15/2017 |
| K111243 | FUJINON INC. | FUJINON ULTRASONIC PROCESSOR | 05/16/2011 |
| K042043 | FUJINON, INC. | FUJINON INC. G5 GASTROSCOPES, MODELS EC-450WR5, EC-250WR5 | 11/24/2004 |
| K063316 | FUJINON, INC. | FUJINON MODEL EG-530N TRANS NASAL INSERTION | 03/16/2007 |
| K063847 | FUJINON, INC. | FUJINON ULTRASONIC ENDOSCOPE AND PROCESSOR, MODELS EG-530UR, EG-530UT AND SU-700 | 03/01/2007 |
| K120446 | FUJINON, INC. | FUJINON/FUJIFILM ULTRASONIC ENDOSCOPE EG-530UR2 AND EG-530UT2 | 08/13/2012 |
| K140295 | GI SCIENTIFIC LLC | GIS ENDOSCOPIC OPTICAL LENS | 07/24/2014 |
| K192704 | HuiZhou Xzing Technology Co., Ltd. | Endofresh Digestive Endoscopy System | 09/02/2020 |
| K060907 | KARL STORZ ENDOSCOPY-AMERICA, INC. | KARL STORZ VIDEO GASTROSCOPES | 11/09/2006 |
| K210915 | Neptune Medical, Inc. | Pathfinder Endoscope Cap | 05/25/2021 |
| K984358 | OLYMPUS AMERICA, INC. | OLYMPUS DISTAL ATTACHMENT, MODELS MH-462,-463,-464,-465,-466,-483,-587,-588,-589,-590,-591,-592,-593,-594,-595,-596,-597 | 09/17/1999 |
| K971660 | OLYMPUS AMERICA, INC. | OLYMPUS GF-UM130 ULTRASOUND GASTROVIDEOSCOPE, ITS ASSOCIATED ACCESSORIES AND ANCILLARY EQUIPMENT | 07/25/1997 |
| K963023 | OLYMPUS AMERICA, INC. | ULTRASOUND GASTROSCOPE GF TYPE UM30P | 02/07/1997 |
| K123317 | OLYMPUS MEDICAL SYSTEMS CORPORATION | EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIXP190N | 12/11/2012 |
| K002231 | OLYMPUS OPTICAL CO., LTD. | LF-DP GASTROINTESTINAL AND SIGMOID FIBERSCOPE, ACCESSORIES AND ANCILLARY EQUIPMENT | 01/30/2001 |
| K021886 | OLYMPUS OPTICAL CO., LTD. | OLYMPUS ULTRASONIC GASTROVIDEOSCOPE GF TYPE UC140P-DO5 & OLYMPUS ULTRASONIC GASTROFIBERSCOPE GF TYPE UC30P | 06/19/2002 |
| K001766 | OLYMPUS OPTICAL CO., LTD. | OLYMPUS XGIF-N200H GASTROINTESTINAL VIDEOSCOPE | 09/08/2000 |
| K032177 | OLYMPUS OPTO-ELECTRONICS CO., LTD. | GASTROINTESTINAL VIDEOSCOPE XGIF-Q14OM, XGIF-2T140M COLONOVIDEOSCOPE XCF-Q14ML/I, XPCF-160AML/I | 10/02/2003 |
| K131902 | PENTAX MEDICAL COMPANY | PENTAX VIDEO UPPER G.I. SCOPES (EG FAMILY) | 04/10/2014 |
| K180292 | PENTAX Medical of America, Inc | PENTAX Video Upper G.I. Scope EG34-i10 | 10/12/2018 |
| K190799 | PENTAX of America, Inc. | PENTAX Medical Video Upper GI Scopes (EG Family) | 11/12/2019 |
| K210485 | PENTAX of America, Inc. | PENTAX Medical Video Upper GI Scopes (EG Family), PENTAX Medical Video Colonoscopes (EC Family) | 05/13/2021 |
| K210177 | PENTAX of America, Inc. | PENTAX Medical Video Upper GI Scopes EG17-J10 | 10/20/2021 |
| K961564 | PENTAX PRECISION INSTRUMENT CORP. | EG-2940, VIDEO GASTROSCOPE | 07/09/1996 |
| K962897 | PENTAX PRECISION INSTRUMENT CORP. | EG-3400, VIDEO GASTROSCOPE | 10/04/1996 |
| K013640 | PENTAX PRECISION INSTRUMENT CORP. | EG-3630UR, ULTRASUND VIDEO GASTROSCOPE | 02/04/2002 |
| K962460 | PENTAX PRECISION INSTRUMENT CORP. | EG-3800T, VIDEO GASTROSCOPE | 09/16/1996 |
| K173004 | Sumitomo Bakelite Co., Ltd | SB Soft Hood - Straight type, SB Soft Hood - Undercut type | 05/08/2018 |
| K011151 | THE OLYMPUS OPTICAL CO. | EVIS EXERA GASTROINTESTINAL VIDEOSCOPE GIF-Q160Z | 05/15/2001 |
| K130148 | UNITED STATES ENDOSCOPY GROUP, INC. | FOREIGN BODY HOOD | 08/07/2013 |
| K180911 | Visura Technologies, LLC | Visura Technologies TEECAD System | 06/20/2018 |
| K971734 | WELCH ALLYN, INC. | VG 200 VIDEO GASTROSCOPE | 07/29/1997 |
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