K250462 is an FDA 510(k) clearance for the UL UHD-Clear View 4K Camera System (UL-3Chip 4K). This device is classified as a Endoscopic Video Imaging System/component, Gastroenterology-urology (Class II - Special Controls, product code FET).
Submitted by Univlabs Technologies Private Limited (Gurugram, IN). The FDA issued a Cleared decision on August 11, 2025, 174 days after receiving the submission on February 18, 2025.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 876.1500. To Allow For Visualization Of Body Cavities Through An Endoscope By Projecting Images To A Monitor..
| 510(k) Number | K250462 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 18, 2025 |
| Decision Date | August 11, 2025 |
| Days to Decision | 174 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | FET - Endoscopic Video Imaging System/component, Gastroenterology-urology |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.1500 |
| Definition | To Allow For Visualization Of Body Cavities Through An Endoscope By Projecting Images To A Monitor. |