FET — Endoscopic Video Imaging System/Component, Gastroenterology-Urology Class II
FDA product code FET covers "Endoscopic Video Imaging System/Component, Gastroenterology-Urology", 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
- FET
- Device Class
- Class II
- Regulation Number
- 876.1500
- Submission Type
- Review Panel
- GU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- No
Definition
To allow for visualization of body cavities through an endoscope by projecting images to a monitor.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K261880 | fujifilm corporation | FUJIFILM Processor EP-8000;Balloon Controller PB-30;Endoscopy Support Program EW | July 2, 2026 |
| K261260 | olympus medical systems corporation | HD Camera Head OLYMPUS CH-S200-08-LB | June 24, 2026 |
| K251734 | proverum limited | ProVee Video Processing Unit (PV-003) | September 24, 2025 |
| K250462 | univlabs technologies private limited | UL UHD-Clear View 4K Camera System (UL-3Chip 4K) | August 11, 2025 |
| K250204 | shenzhen sophway technology co | Endoscopic Camera System | July 1, 2025 |
| K243260 | fujifilm corporation | FUJIFILM Processor EP-8000; FUJIFILM Endoscope Model EG-860R | April 11, 2025 |
| K242067 | olympus corporations of the americas | VISERA ELITE III VIDEO SYSTEM CENTER OLYMPUS OTV-S700; VISERA ELITE III LED LIGH | April 2, 2025 |
| K243321 | guangzhou red pine medical instrument co | Endoscopic Video Image Processor (RP-IPD-V1000F) | February 7, 2025 |
| K241532 | shanghai seegen photoelectric technology co | Flexible Video-Choledo-Cysto-Ureteroscope System (PL-2100) | October 22, 2024 |
| K241371 | olympus medical systems corporation | VISERA S VIDEO SYSTEM CENTER OLYMPUS OTV-S500 (OLYMPUS OTV-S500) | July 3, 2024 |
| K222584 | olympus medical systems corporation | EVIS X1 VIDEO SYSTEM CENTER OLYMPUS CV-1500, COLONOVIDEOSCOPE OLYMPUS CF-HQ1100D | April 26, 2023 |
| K212808 | richard wolf medical instruments corporation | Logic Hd camera head green, System green | June 14, 2022 |
| K221174 | karl storz endoscopy america | Telepack + | May 13, 2022 |
| K211332 | richard wolf medical instruments corporation | D Camera Controller | October 1, 2021 |
| K202646 | olympus medical systems | Visera Elite II Video System Center | October 29, 2020 |
| K201135 | karl storz endoscopy-america | Image1 S CCU, Image1 S 4U Camera Head | September 1, 2020 |
| K201200 | olympus medical systems | Visera Elite II Video System Center | July 22, 2020 |
| K200617 | richard wolf medical instruments corporation | Logic HD Camera Controller, Logic HD Lite Camera Controller, Logic 4K Camera Con | June 23, 2020 |
| K192286 | fujifilm corporation | FUJIFILM EP-6000 Video Processor | May 1, 2020 |
| K193235 | karl storz endoscopy america | Telepack + | December 20, 2019 |