510(k) K250462 ยท FET Endoscopic Video Imaging System/Component, Gastroenterology-Urology
UL UHD-Clear View 4K Camera System (UL-3Chip 4K)
| Applicant | Univlabs Technologies Private Limited, Gurugram, IN |
| Decision | Substantially Equivalent, Aug 11, 2025 |
| Received | Feb 18, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K250462
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.