510(k) K250462— UL UHD-Clear View 4K Camera System (UL-3Chip 4K)

Substantially Equivalent

Univlabs Technologies Private Limited

Clearance details

Applicant: Univlabs Technologies Private Limited
Product code: Code FET
Advisory panel: Gastroenterology, Urology
Date received: 2025-02-18
Decision date: 2025-08-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gurugram, IN

Adverse events under product code FET

product code FET

Injury: 313
Malfunction: 54,276
Total: 54,589

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.