FDS — Gastroscope And Accessories, Flexible/Rigid Class II
FDA product code FDS covers "Gastroscope And Accessories, Flexible/Rigid", a Class II medical device regulated under 21 CFR 876.1500. Submissions are reviewed by the Gastroenterology, Urology panel. At least 20 recent 510(k) clearances have been granted under this product code.
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 |
|---|---|---|---|
| K260573 | evoendo | EvoEndo Single-Use Endoscopy System | April 21, 2026 |
| 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 |