FDA Product Code
FDA Product Code FDS — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Gastroenterology, Urology
- 21 CFR Citation
- 876.1500
510(k) Clearances — 79 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K261400 | Ambu® aScope Gastro; Ambu® aScope Gastro Large | Ambu A/S | 2026-09-16 | Traditional | PDF ↗ |
| K260856 | Disposable Distal Attachment D-201-13404 | Olympus Medical Systems Corporation | 2026-08-27 | Traditional | PDF ↗ |
| K260824 | Gastrointestinal Videoscope Olympus GIF-2T1500 | Olympus Medical Systems Corporation | 2026-08-27 | Traditional | PDF ↗ |
| K253702 | Intuitive Endoluminal Gastrointestinal System (IG1000) | Intuitive Surgical, Inc. | 2026-08-07 | Traditional | PDF ↗ |
| K260573 | EvoEndo Single-Use Endoscopy System | EvoEndo, Inc. | 2026-04-21 | Traditional | PDF ↗ |
| K250550 | FUJIFILM Endoscope Model EG-S100XT and VS-1000 Display Unit | Fujifilm Corporation | 2026-02-17 | Traditional | PDF ↗ |
| K253568 | Hood DH-084STR; Hood DH-094STR; Hood DH-104STR; Hood DH-114STR; Hood DH-124STR; Hood DH-134STR | Fujifilm Corporation | 2026-02-06 | Special | PDF ↗ |
| K251256 | PENTAX Medical Video Upper GI Scopes (EG Family) (EG Family); PENTAX Medical Video Colonoscopes (EC Family) (EC Family) | Pentax of America, Inc. | 2025-12-16 | Traditional | PDF ↗ |
| K251041 | GripTract-GI Endoscopic Tissue Manipulator Upper GI Model GT-GS100 | Actuated Medical, Inc. | 2025-10-31 | Traditional | PDF ↗ |
| K251708 | EvoEndo Single-Use Endoscopy System | EvoEndo, Inc. | 2025-10-10 | Traditional | PDF ↗ |
| K243388 | Disposable Distal Cap | Micro-Tech (Nanjing) Co., Ltd. | 2025-06-27 | Traditional | PDF ↗ |
| K250900 | EvoEndo Single-Use Endoscopy System | EvoEndo, Inc. | 2025-06-16 | Traditional | PDF ↗ |
| K243512 | FUJIFILM Endoscope Model EG-840N; FUJIFILM Endoscope Model EG-840T; FUJIFILM Endoscope Model EG-840TP | Fujifilm Corporation | 2025-06-10 | Traditional | PDF ↗ |
| K242635 | Endoscopic Distal Attachment (AF-D series) | Alton (Shanghai) Medical Instruments Co., Ltd. | 2025-05-30 | Traditional | PDF ↗ |
| K250296 | Disposable Distal Attachment D-201 Series | Olympus Medical Systems Corp. | 2025-05-01 | Traditional | PDF ↗ |
| K241213 | PENTAX Medical Video Upper GI Scope (EG27-i20c); PENTAX Medical Video Colonoscope (EC34-i20cL) | Pentax of America, Inc. | 2024-12-06 | Traditional | PDF ↗ |
| K242779 | Hood (DH-083ST) | Fujifilm Corporation | 2024-10-11 | Special | PDF ↗ |
| K240142 | FUJIFILM Endoscope Model EG-840N; FUJIFILM Endoscope Model EG-840T; FUJIFILM Endoscope Model EG-840TP | Fujifilm Corporation | 2024-09-04 | Traditional | PDF ↗ |
| K232997 | EVIS Exera III Gastrointestinal Videoscope GIF-1TH190 | Olympus Medical Systems Corporation | 2024-06-19 | Traditional | PDF ↗ |
| K232919 | Ambu® aScope Gastro Large; Ambu® aBox 2 | Ambu A/S | 2024-04-05 | Traditional | PDF ↗ |
| K232028 | Q Vision Sterile Single Use Adult Flexible Gastroscope (G-100); Q Base Reusable Base Unit (Q-100) | Iq Endoscopes Limited | 2023-11-17 | Traditional | PDF ↗ |
| K232314 | Hood (DH-106STL, DH-116STL, DH-126STL, DH-096ST) | FUJIFILM Healthcare Americas Corporation | 2023-09-01 | Special | PDF ↗ |
| K221551 | FUJIFILM Endoscope Model EI-740D/S | Fujifilm Corporaton | 2023-01-27 | Traditional | PDF ↗ |
| K213606 | EvoEndo Single-Use Endoscopy System | EvoEndo, Inc. | 2022-02-14 | Traditional | PDF ↗ |
| K212382 | Ambu® aScope Gastro, Ambu® aBox2 | Ambu A/S | 2022-02-03 | Traditional | PDF ↗ |
| K210177 | PENTAX Medical Video Upper GI Scopes EG17-J10 | Pentax of America, Inc. | 2021-10-20 | Traditional | PDF ↗ |
| K212296 | Distal Cap Model DH-32EN, Distal Cap Model DH-17EN2 | Fujifilm Corporation | 2021-08-19 | Special | PDF ↗ |
| K210915 | Pathfinder Endoscope Cap | Neptune Medical, Inc. | 2021-05-25 | Traditional | PDF ↗ |
| K210485 | PENTAX Medical Video Upper GI Scopes (EG Family), PENTAX Medical Video Colonoscopes (EC Family) | Pentax of America, Inc. | 2021-05-13 | Traditional | PDF ↗ |
| K210162 | Endoscope Model EI-740D/S | Fujifilm Corporation | 2021-04-09 | Traditional | PDF ↗ |
| K192704 | Endofresh Digestive Endoscopy System | Huizhou Xzing Technology Co., Ltd. | 2020-09-02 | Traditional | PDF ↗ |
| K200850 | Fujifilm Ultrasonic Processor | Fujifilm Corporation | 2020-07-06 | Special | PDF ↗ |
| K193123 | FUJIFILM Distal Cap Models 33-40 | Fujifilm Corporation | 2019-12-11 | Special | PDF ↗ |
| K190799 | PENTAX Medical Video Upper GI Scopes (EG Family) | Pentax of America, Inc. | 2019-11-12 | Traditional | PDF ↗ |
| K183572 | FUJIFILM Endoscope Models EG-760CT, EC-760P-V/L and EC-740T/L | Fujifilm Corporation | 2019-07-16 | Traditional | PDF ↗ |
| K182836 | FUJIFILM Endoscope Model EG-740N | Fujifilm Corporation | 2019-04-02 | Traditional | PDF ↗ |
| K183686 | FUJIFILM Endoscope Model EG-530N | Fujifilm Corporation | 2019-02-28 | Special | PDF ↗ |
| K180292 | PENTAX Video Upper G.I. Scope EG34-i10 | Pentax Medical of America, Inc. | 2018-10-12 | Traditional | PDF ↗ |
| K180341 | FUJIFILM 600 Series Endoscope EG-600WR v2 | Fujifilm Corporation | 2018-08-03 | Special | PDF ↗ |
| K181763 | FUJIFILM Ultrasonic Endoscope | Fujifilm Corporation | 2018-07-27 | Special | PDF ↗ |
| K180911 | Visura Technologies TEECAD System | Visura Technologies, LLC | 2018-06-20 | Traditional | PDF ↗ |
| K173004 | SB Soft Hood - Straight type, SB Soft Hood - Undercut type | Sumitomo Bakelite Co., Ltd. | 2018-05-08 | Traditional | PDF ↗ |
| K172916 | FUJIFILM Endoscope Models EG-760R, EG-760Z, EC-760R-V/L and EC-760ZP-V/L, and FUJIFILM Water Tank Model WT-603 | Fujifilm Corporation | 2018-03-01 | Traditional | PDF ↗ |
| K162749 | FUJIFILM Hood Models DH-28GR, DH-29CR and DH-30CR | Fujifilm Medical Systems U.S.A, Inc. | 2017-06-15 | Traditional | PDF ↗ |
| K153206 | Fujifilm Ultrasonic Processors SU-1 PLATINUM and SU-1 | Fujifilm Medical System U.S.A., Inc. | 2016-03-03 | Traditional | PDF ↗ |
| K152182 | Fuse Gastroscopy System | Endochoice, Inc. | 2015-12-10 | Special | PDF ↗ |
| K142629 | EG-530CT, EG-530D, EC-530DL, and ES-530WE Endoscopes | Fujifilm Medical System U.S.A., Inc. | 2015-05-14 | Traditional | PDF ↗ |
| K140295 | GIS ENDOSCOPIC OPTICAL LENS | Gi Scientific, LLC | 2014-07-24 | Traditional | PDF ↗ |
| K131902 | PENTAX VIDEO UPPER G.I. SCOPES (EG FAMILY) | Pentax Medical Company | 2014-04-10 | Traditional | PDF ↗ |
| K131422 | PEERSCOPE SYSTEM | Endochoice, Inc. | 2013-10-10 | Traditional | PDF ↗ |
| K130148 | FOREIGN BODY HOOD | United States Endoscopy Group, Inc. | 2013-08-07 | Traditional | PDF ↗ |
| K123317 | EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIXP190N | Olympus Medical Systems Corporation | 2012-12-11 | Special | PDF ↗ |
| K120446 | FUJINON/FUJIFILM ULTRASONIC ENDOSCOPE EG-530UR2 AND EG-530UT2 | Fujinon, Inc. | 2012-08-13 | Traditional | PDF ↗ |
| K113166 | CLEARPATH UPPER GI | Easyglide , Ltd. | 2012-05-16 | Special | PDF ↗ |
| K111243 | FUJINON ULTRASONIC PROCESSOR | Fujinon, Inc. | 2011-05-16 | Special | PDF ↗ |
| K093779 | CLEARPATH UGI | Easyglide , Ltd. | 2010-03-09 | Traditional | PDF ↗ |
| K063316 | FUJINON MODEL EG-530N TRANS NASAL INSERTION | Fujinon, Inc. | 2007-03-16 | Traditional | PDF ↗ |
| K063847 | FUJINON ULTRASONIC ENDOSCOPE AND PROCESSOR, MODELS EG-530UR, EG-530UT AND SU-700 | Fujinon, Inc. | 2007-03-01 | Traditional | PDF ↗ |
| K060907 | KARL STORZ VIDEO GASTROSCOPES | KARL STORZ Endoscopy-America, Inc. | 2006-11-09 | Traditional | PDF ↗ |
| K042043 | FUJINON INC. G5 GASTROSCOPES, MODELS EC-450WR5, EC-250WR5 | Fujinon, Inc. | 2004-11-24 | Traditional | PDF ↗ |
| K032177 | GASTROINTESTINAL VIDEOSCOPE XGIF-Q14OM, XGIF-2T140M COLONOVIDEOSCOPE XCF-Q14ML/I, XPCF-160AML/I | Olympus Opto-Electronics Co., Ltd. | 2003-10-02 | Traditional | PDF ↗ |
| K021886 | OLYMPUS ULTRASONIC GASTROVIDEOSCOPE GF TYPE UC140P-DO5 & OLYMPUS ULTRASONIC GASTROFIBERSCOPE GF TYPE UC30P | Olympus Optical Co., Ltd. | 2002-06-19 | Traditional | PDF ↗ |
| K013640 | EG-3630UR, ULTRASUND VIDEO GASTROSCOPE | Pentax Precision Instrument Corp. | 2002-02-04 | Traditional | PDF ↗ |
| K011151 | EVIS EXERA GASTROINTESTINAL VIDEOSCOPE GIF-Q160Z | The Olympus Optical Co. | 2001-05-15 | Special | PDF ↗ |
| K002231 | LF-DP GASTROINTESTINAL AND SIGMOID FIBERSCOPE, ACCESSORIES AND ANCILLARY EQUIPMENT | Olympus Optical Co., Ltd. | 2001-01-30 | Traditional | PDF ↗ |
| K001766 | OLYMPUS XGIF-N200H GASTROINTESTINAL VIDEOSCOPE | Olympus Optical Co., Ltd. | 2000-09-08 | Traditional | PDF ↗ |
| K984358 | OLYMPUS DISTAL ATTACHMENT, MODELS MH-462,-463,-464,-465,-466,-483,-587,-588,-589,-590,-591,-592,-593,-594,-595,-596,-597 | Olympus America, Inc. | 1999-09-17 | Traditional | PDF ↗ |
| K974493 | FIEGERT ENDOTECH FLEXIBLE FIBEROPTIC ENDOSCOPES, FIEGERT ENDOTECH FLEXIBLE VIDEO-ENDOSCOPES | Fiegert-Endotech Medizintechnik GmbH | 1998-03-31 | Traditional | PDF ↗ |
| K971734 | VG 200 VIDEO GASTROSCOPE | Welch Allyn, Inc. | 1997-07-29 | Traditional | PDF ↗ |
| K971660 | OLYMPUS GF-UM130 ULTRASOUND GASTROVIDEOSCOPE, ITS ASSOCIATED ACCESSORIES AND ANCILLARY EQUIPMENT | Olympus America, Inc. | 1997-07-25 | Traditional | PDF ↗ |
| K963023 | ULTRASOUND GASTROSCOPE GF TYPE UM30P | Olympus America, Inc. | 1997-02-07 | Traditional | PDF ↗ |
| K962897 | EG-3400, VIDEO GASTROSCOPE | Pentax Precision Instrument Corp. | 1996-10-04 | Traditional | PDF ↗ |
| K962460 | EG-3800T, VIDEO GASTROSCOPE | Pentax Precision Instrument Corp. | 1996-09-16 | Traditional | PDF ↗ |
| K961564 | EG-2940, VIDEO GASTROSCOPE | Pentax Precision Instrument Corp. | 1996-07-09 | Traditional | PDF ↗ |
| K943715 | VISION SYSTEM UPPER G.I. EXDOSCOPE | Vision-Sciences, Inc. | 1995-02-24 | Traditional | PDF ↗ |
| K933717 | OLYMPUS MEASURING DEVICES | Olympus Corp. | 1993-11-02 | Traditional | PDF ↗ |
| K850020 | PENTAX PNE- ULTRA-SLIM UPPER G.I. FIBERSCOPE FG-23 | Pentax Precision Instrument Corp. | 1985-07-09 | Traditional | PDF ↗ |
| K833924 | TWO CHANNEL GASTROFIBERSCOPE FG-36T | Pentax Precision Instrument Corp. | 1984-02-04 | Traditional | PDF ↗ |
| K832007 | PENTAX FG-34JA GASTROFIBERSCOPE | Pentax Precision Instrument Corp. | 1983-08-11 | Traditional | PDF ↗ |
Product code FDS · Class II · Gastroenterology, Urology. Data: openFDA.