Product code FDS
- Device name
- Gastroscope And Accessories, Flexible/Rigid
- Medical specialty
- Gastroenterology, Urology
- Device class
- 2
- Regulation number
- 876.1500
- Review panel
- GU
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- Definition
- To examine or perform procedures in the stomach. For reusable, flexible endoscopes in this product code, validated reprocessing instructions and reprocessing validation data must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K260573 | EvoEndo Single-Use Endoscopy System | EvoEndo, Inc. | 2026-04-21 |
| K250550 | FUJIFILM Endoscope Model EG-S100XT and VS-1000 Display Unit | Fujifilm Corporation | 2026-02-17 |
| K253568 | Hood DH-084STR; Hood DH-094STR; Hood DH-104STR; Hood DH-114STR; Hood DH-124STR; Hood DH-134STR | Fujifilm Corporation | 2026-02-06 |
| 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 |
| K251041 | GripTract-GI™ Endoscopic Tissue Manipulator Upper GI Model GT-GS100 | Actuated Medical, Inc. | 2025-10-31 |
| K251708 | EvoEndo Single-Use Endoscopy System | EvoEndo, Inc. | 2025-10-10 |
| K243388 | Disposable Distal Cap | Micro-Tech (Nanjing) Co., Ltd. | 2025-06-27 |
| K250900 | EvoEndo Single-Use Endoscopy System | EvoEndo, Inc. | 2025-06-16 |
| K243512 | FUJIFILM Endoscope Model EG-840N; FUJIFILM Endoscope Model EG-840T; FUJIFILM Endoscope Model EG-840TP | Fujifilm Corporation | 2025-06-10 |
| K242635 | Endoscopic Distal Attachment (AF-D series) | Alton (Shanghai) Medical Instruments Co., Ltd. | 2025-05-30 |
| K250296 | Disposable Distal Attachment D-201 Series | Olympus Medical Systems Corp. | 2025-05-01 |
| K241213 | PENTAX Medical Video Upper GI Scope (EG27-i20c); PENTAX Medical Video Colonoscope (EC34-i20cL) | Pentax of America, Inc. | 2024-12-06 |
| K242779 | Hood (DH-083ST) | Fujifilm Corporation | 2024-10-11 |
| K240142 | FUJIFILM Endoscope Model EG-840N; FUJIFILM Endoscope Model EG-840T; FUJIFILM Endoscope Model EG-840TP | Fujifilm Corporation | 2024-09-04 |
| K232997 | EVIS Exera III Gastrointestinal Videoscope GIF-1TH190 | Olympus Medical Systems Corporation | 2024-06-19 |
| K232919 | Ambu® aScope™ Gastro Large; Ambu® aBox™ 2 | Ambu A/S | 2024-04-05 |
| K232028 | Q Vision Sterile Single Use Adult Flexible Gastroscope (G-100); Q Base Reusable Base Unit (Q-100) | Iq Endoscopes Limited | 2023-11-17 |
| K232314 | Hood (DH-106STL, DH-116STL, DH-126STL, DH-096ST) | FUJIFILM Healthcare Americas Corporation | 2023-09-01 |
| K221551 | FUJIFILM Endoscope Model EI-740D/S | Fujifilm Corporaton | 2023-01-27 |
| K213606 | EvoEndo Single-Use Endoscopy System | EvoEndo, Inc. | 2022-02-14 |
| K212382 | Ambu® aScope™ Gastro, Ambu® aBox™2 | Ambu A/S | 2022-02-03 |
| K210177 | PENTAX Medical Video Upper GI Scopes EG17-J10 | Pentax of America, Inc. | 2021-10-20 |
| K212296 | Distal Cap Model DH-32EN, Distal Cap Model DH-17EN2 | Fujifilm Corporation | 2021-08-19 |
| K210915 | Pathfinder Endoscope Cap | Neptune Medical, Inc. | 2021-05-25 |
| K210485 | PENTAX Medical Video Upper GI Scopes (EG Family), PENTAX Medical Video Colonoscopes (EC Family) | Pentax of America, Inc. | 2021-05-13 |
| K210162 | Endoscope Model EI-740D/S | Fujifilm Corporation | 2021-04-09 |
| K192704 | Endofresh Digestive Endoscopy System | Huizhou Xzing Technology Co., Ltd. | 2020-09-02 |
| K200850 | Fujifilm Ultrasonic Processor | Fujifilm Corporation | 2020-07-06 |
| K193123 | FUJIFILM Distal Cap Models 33-40 | Fujifilm Corporation | 2019-12-11 |
| K190799 | PENTAX Medical Video Upper GI Scopes (EG Family) | Pentax of America, Inc. | 2019-11-12 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00850006222322 | Pathfinder® CR System | NEPTUNE MEDICAL INC. | 2024-07-09 |
| 14961333079343 | PENTAX | HOYA CORPORATION | 2023-07-31 |
| 14961333085535 | PENTAX | HOYA CORPORATION | 2023-07-31 |
| 04547410138511 | FUJIFILM | FUJIFILM CORPORATION | 2022-10-07 |
| 00860226002536 | Visura TEECAD Carrier Control Unit | VISURA TECHNOLOGIES, INC. | 2022-07-26 |
| 04547410395136 | FUJIFILM | FUJIFILM CORPORATION | 2020-01-30 |
| 04547410395105 | FUJIFILM | FUJIFILM CORPORATION | 2020-01-30 |
| 04547410349078 | FUJIFILM | FUJIFILM CORPORATION | 2019-09-30 |
| 04547410349061 | FUJIFILM | FUJIFILM CORPORATION | 2019-09-30 |
| 04547410368871 | FUJIFILM | FUJIFILM CORPORATION | 2019-09-09 |
| 04547410368857 | FUJIFILM | FUJIFILM CORPORATION | 2019-09-09 |
| 00860226002512 | TEECAD | VISURA TECHNOLOGIES, INC. | 2019-07-06 |
| 00860226002505 | TEECAD | VISURA TECHNOLOGIES, INC. | 2019-07-06 |
| 04545499068866 | SB Soft Hood /Straight type | SB-KAWASUMI LABORATORIES, INC. | 2018-09-30 |
| 04545499068873 | SB Soft Hood /Undercut type | SB-KAWASUMI LABORATORIES, INC. | 2018-09-30 |
| 04545499068880 | SB Soft Hood /Straight type | SB-KAWASUMI LABORATORIES, INC. | 2018-09-30 |
| 04545499068897 | SB Soft Hood /Undercut type | SB-KAWASUMI LABORATORIES, INC. | 2018-09-30 |
| 04545499068903 | SB Soft Hood /Straight type | SB-KAWASUMI LABORATORIES, INC. | 2018-09-30 |
| 04545499068910 | SB Soft Hood /Undercut type | SB-KAWASUMI LABORATORIES, INC. | 2018-09-30 |
| 00821925035966 | PlasmaKinetic | Gyrus ACMI, LLC | 2018-09-13 |
| 04547410366044 | FUJIFILM | FUJIFILM CORPORATION | 2018-03-27 |
| 04547410358674 | FUJIFILM | FUJIFILM CORPORATION | 2018-03-27 |
| 04547410358681 | FUJIFILM | FUJIFILM CORPORATION | 2018-03-27 |
| 04547410358698 | FUJIFILM | FUJIFILM CORPORATION | 2018-03-27 |
| 04547410331660 | FUJIFILM | FUJIFILM CORPORATION | 2017-07-21 |
| 04547410331677 | FUJIFILM | FUJIFILM CORPORATION | 2017-07-21 |
| 04547410331653 | FUJIFILM | FUJIFILM CORPORATION | 2017-07-21 |
| 00821925039568 | PlasmaKinetic | Gyrus ACMI, LLC | 2016-10-06 |
| 00821925035959 | PlasmaKinetic | Gyrus ACMI, LLC | 2016-10-06 |
| 14953170247573 | SINGLE USE BIOPSY VALVE | OLYMPUS MEDICAL SYSTEMS CORP. | 2016-09-21 |