FET
- Product code
- FET
- Device name
- Endoscopic Video Imaging System/Component, Gastroenterology-Urology
- Device class
- Class 2
- 21 CFR
- 21 CFR 876.1500
- Medical specialty
- Gastroenterology, Urology
- Marketing pathway
- 510(K)
- 510(k) clearances (last 3 years)
- 10
- Summaries archived here
- 8 (direct download)
- 510(k) clearances (all years, FDA)
- 100 (all years; only the last 3 years are listed here)
FDA classification definition
To allow for visualization of body cavities through an endoscope by projecting images to a monitor.
510(k) clearances, last 3 years (10)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K261880 | 2026-07-02 | Fujifilm Corporation | FUJIFILM Processor EP-8000;Balloon Controller PB-30;… | FDA |
| K261260 | 2026-06-24 | Olympus Medical Systems Corporation | HD Camera Head OLYMPUS CH-S200-08-LB | |
| K251734 | 2025-09-24 | Proverum Limited | ProVee Video Processing Unit (PV-003) | |
| K250462 | 2025-08-11 | Univlabs Technologies Private Limited | UL UHD-Clear View 4K Camera System (UL-3Chip 4K) | |
| K250204 | 2025-07-01 | Shenzhen Sophway Technology Co., Ltd. | Endoscopic Camera System | |
| K243260 | 2025-04-11 | Fujifilm Corporation | FUJIFILM Processor EP-8000; FUJIFILM Endoscope Model… | |
| K242067 | 2025-04-02 | Olympus Corporations of the Americas | VISERA ELITE III VIDEO SYSTEM CENTER OLYMPUS OTV-S70… | |
| K243321 | 2025-02-07 | Guangzhou Red Pine Medical Instrument … | Endoscopic Video Image Processor (RP-IPD-V1000F) | FDA |
| K241532 | 2024-10-22 | Shanghai SeeGen Photoelectric Technolo… | Flexible Video-Choledo-Cysto-Ureteroscope System (PL… | |
| K241371 | 2024-07-03 | Olympus Medical Systems Corporation | VISERA S VIDEO SYSTEM CENTER OLYMPUS OTV-S500 (OLYMP… |
Official FDA classification page: FET
Classification and pathway per current FDA publications. Data from openFDA (CC0).