FDA product code FET: Endoscopic Video Imaging System/Component, Gastroenterology-Urology
FET is the FDA product code for endoscopic video imaging system/component, gastroenterology-urology. It is a Class II device, regulated under 21 CFR 876.1500 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 101 510(k) submissions under FET, 14 in the last five years, from 56 different applicants. The average 510(k) review took 105 days (median 81); 107 days on average over the last three years. FDA has posted 8 recalls for FET devices, 3 initiated in the last five years.
Definition
To allow for visualization of body cavities through an endoscope by projecting images to a monitor.
Classification
| Field | Value |
|---|---|
| Device name | Endoscopic Video Imaging System/Component, Gastroenterology-Urology |
| Device class | Class II |
| Regulation | 21 CFR 876.1500 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) |
510(k) clearances per year for FET
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 3 | 135 |
| 2018 | 3 | 89 |
| 2019 | 3 | 76 |
| 2020 | 5 | 122 |
| 2021 | 1 | 151 |
| 2022 | 2 | 151 |
| 2023 | 1 | 243 |
| 2024 | 2 | 97 |
| 2025 | 6 | 165 |
| 2026 | 3 | 59 |
Compare with all 510(k) review times · Search every FET clearance
Top FET applicants
| Applicant | Clearances | Latest |
|---|---|---|
| KARL STORZ Endoscopy-America, Inc. | 10 | 2020-09-01 |
| Olympus Medical Systems Corp. | 5 | 2026-09-10 |
| Olympus Medical Systems Corporation | 5 | 2026-06-24 |
| Richard Wolf Medical Instruments Corporation | 5 | 2022-06-14 |
| Karl Storz Imaging, Inc. | 5 | 2001-04-27 |
51 more applicants have FET clearances. See the full list in Caduvo.
Most recent FET clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K262079 | Olympus Medical Systems Corp. | 4K Camera Head OLYMPUS CH-S700-08-LB | 2026-09-10 | 80 |
| K261880 | Fujifilm Corporation | FUJIFILM Processor EP-8000;Balloon Controller PB-30;Endoscopy Support Program EW10-VM01 | 2026-07-02 | 27 |
| K261260 | Olympus Medical Systems Corporation | HD Camera Head OLYMPUS CH-S200-08-LB | 2026-06-24 | 69 |
| K251734 | Proverum Limited | ProVee Video Processing Unit (PV-003) | 2025-09-24 | 110 |
| K250462 | Univlabs Technologies Private Limited | UL UHD-Clear View 4K Camera System (UL-3Chip 4K) | 2025-08-11 | 174 |
Recalls for FET devices
8 product recalls in 5 recall events; 3 initiated in the last five years and 3 still open. Most recent: 2024-08-21.
| Year | Recalls |
|---|---|
| 2018 | 2 |
| 2023 | 2 |
| 2024 | 1 |
Frequently asked questions
What is FDA product code FET?
FET is the FDA product code for endoscopic video imaging system/component, gastroenterology-urology. It is a Class II device, regulated under 21 CFR 876.1500 and reviewed by the Gastroenterology and Urology panel.
What device class is FET?
Class II, regulation 21 CFR 876.1500. Typical premarket route: 510(k).
How long does a 510(k) take for product code FET?
Across 101 cleared submissions the average was 105 days from receipt to decision (median 81).
Which companies have the most FET clearances?
KARL STORZ Endoscopy-America, Inc. (10); Olympus Medical Systems Corp. (5); Olympus Medical Systems Corporation (5); Richard Wolf Medical Instruments Corporation (5); Karl Storz Imaging, Inc. (5).
Have FET devices been recalled?
Yes: 8 product recalls across 5 recall events; the most recent began 2024-08-21.
Next steps
- Run an FDA pathway report with predicate devices for product code FET
- Run a recall and safety report across every FET manufacturer
- Watch product code FET for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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