FDS — Gastroscope And Accessories, Flexible/Rigid Class II
Classification Details
- Product Code
- FDS
- Device Class
- Class II
- Regulation Number
- 876.1500
- Submission Type
- Review Panel
- GU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- No
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).
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K250550 | fujifilm corporation | FUJIFILM Endoscope Model EG-S100XT and VS-1000 Display Unit | February 17, 2026 |
| K253568 | fujifilm corporation | Hood DH-084STR; Hood DH-094STR; Hood DH-104STR; Hood DH-114STR; Hood DH-124STR; | February 6, 2026 |
| K251256 | pentax of america | PENTAX Medical Video Upper GI Scopes (EG Family) (EG Family); PENTAX Medical Vid | December 16, 2025 |
| K251041 | actuated medical | GripTract-GI Endoscopic Tissue Manipulator Upper GI Model GT-GS100 | October 31, 2025 |
| K251708 | evoendo | EvoEndo Single-Use Endoscopy System | October 10, 2025 |
| K243388 | micro-tech (nanjing) co | Disposable Distal Cap | June 27, 2025 |
| K250900 | evoendo | EvoEndo Single-Use Endoscopy System | June 16, 2025 |
| K243512 | fujifilm corporation | FUJIFILM Endoscope Model EG-840N; FUJIFILM Endoscope Model EG-840T; FUJIFILM End | June 10, 2025 |
| K242635 | alton (shanghai) medical instruments co | Endoscopic Distal Attachment (AF-D series) | May 30, 2025 |
| K250296 | olympus medical systems | Disposable Distal Attachment D-201 Series | May 1, 2025 |
| K241213 | pentax of america | PENTAX Medical Video Upper GI Scope (EG27-i20c); PENTAX Medical Video Colonoscop | December 6, 2024 |
| K242779 | fujifilm corporation | Hood (DH-083ST) | October 11, 2024 |
| K240142 | fujifilm corporation | FUJIFILM Endoscope Model EG-840N; FUJIFILM Endoscope Model EG-840T; FUJIFILM End | September 4, 2024 |
| K232997 | olympus medical systems corporation | EVIS Exera III Gastrointestinal Videoscope GIF-1TH190 | June 19, 2024 |
| K232919 | ambu | Ambu® aScope Gastro Large; Ambu® aBox 2 | April 5, 2024 |
| K232028 | iq endoscopes limited | Q Vision Sterile Single Use Adult Flexible Gastroscope (G-100); Q Base Reusable | November 17, 2023 |
| K232314 | fujifilm healthcare americas corporation | Hood (DH-106STL, DH-116STL, DH-126STL, DH-096ST) | September 1, 2023 |
| K221551 | fujifilm corporaton | FUJIFILM Endoscope Model EI-740D/S | January 27, 2023 |
| K213606 | evoendo | EvoEndo Single-Use Endoscopy System | February 14, 2022 |
| K212382 | ambu | Ambu® aScope Gastro, Ambu® aBox2 | February 3, 2022 |