FDS
- Product code
- FDS
- Device name
- Gastroscope And Accessories, Flexible/Rigid
- Device class
- Class 2
- 21 CFR
- 21 CFR 876.1500
- Medical specialty
- Gastroenterology, Urology
- Marketing pathway
- 510(K)
- 510(k) clearances (last 3 years)
- 20
- Summaries archived here
- 17 (direct download)
- 510(k) clearances (all years, FDA)
- 78 (all years; only the last 3 years are listed here)
FDA classification 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).
510(k) clearances, last 3 years (20)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K260824 | 2026-08-27 | Olympus Medical Systems Corporation | Gastrointestinal Videoscope Olympus GIF-2T1500 | |
| K260856 | 2026-08-27 | Olympus Medical Systems Corporation | Disposable Distal Attachment D-201-13404 | |
| K253702 | 2026-08-07 | Intuitive Surgical, Inc. | Intuitive Endoluminal Gastrointestinal System (IG100… | |
| K260573 | 2026-04-21 | EvoEndo, Inc. | EvoEndo Single-Use Endoscopy System | |
| K250550 | 2026-02-17 | Fujifilm Corporation | FUJIFILM Endoscope Model EG-S100XT and VS-1000 Displ… | |
| K253568 | 2026-02-06 | Fujifilm Corporation | Hood DH-084STR; Hood DH-094STR; Hood DH-104STR; Hood… | |
| K251256 | 2025-12-16 | Pentax of America, Inc. | PENTAX Medical Video Upper GI Scopes (EG Family) (EG… | |
| K251041 | 2025-10-31 | Actuated Medical, Inc. | GripTract-GI Endoscopic Tissue Manipulator Upper GI… | |
| K251708 | 2025-10-10 | EvoEndo, Inc. | EvoEndo Single-Use Endoscopy System | |
| K243388 | 2025-06-27 | Micro-Tech (Nanjing) Co., Ltd. | Disposable Distal Cap | FDA |
| K250900 | 2025-06-16 | EvoEndo, Inc. | EvoEndo Single-Use Endoscopy System | FDA |
| K243512 | 2025-06-10 | Fujifilm Corporation | FUJIFILM Endoscope Model EG-840N; FUJIFILM Endoscope… | FDA |
| K242635 | 2025-05-30 | Alton (Shanghai) Medical Instruments C… | Endoscopic Distal Attachment (AF-D series) | |
| K250296 | 2025-05-01 | Olympus Medical Systems Corp. | Disposable Distal Attachment D-201 Series | |
| K241213 | 2024-12-06 | Pentax of America, Inc. | PENTAX Medical Video Upper GI Scope (EG27-i20c); PEN… | |
| K242779 | 2024-10-11 | Fujifilm Corporation | Hood (DH-083ST) | |
| K240142 | 2024-09-04 | Fujifilm Corporation | FUJIFILM Endoscope Model EG-840N; FUJIFILM Endoscope… | |
| K232997 | 2024-06-19 | Olympus Medical Systems Corporation | EVIS Exera III Gastrointestinal Videoscope GIF-1TH19… | |
| K232919 | 2024-04-05 | Ambu A/S | Ambu® aScope Gastro Large; Ambu® aBox 2 | |
| K232028 | 2023-11-17 | Iq Endoscopes Limited | Q Vision Sterile Single Use Adult Flexible Gastrosco… |
Official FDA classification page: FDS
Classification and pathway per current FDA publications. Data from openFDA (CC0).