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

Name: FDA 510(k) clearance K250462
Creator: U.S. Food and Drug Administration
Published: 2025-08-11

Substantially Equivalent

Univlabs Technologies Private Limited

FDA 510(k) clearance K250462 for UL UHD-Clear View 4K Camera System (UL-3Chip 4K), Substantially Equivalent on 2025-08-11. Applicant: Univlabs Technologies Private Limited. Device class: 2.

Clearance details

Applicant: Univlabs Technologies Private Limited
Product code: Code FET
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 2025-02-18
Decision date: 2025-08-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gurugram, IN

Download summary PDF View on FDA.gov ↗

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K261260 — HD Camera Head OLYMPUS CH-S200-08-LB2026-06-24
K251734 — ProVee Video Processing Unit (PV-003)2025-09-24
K250204 — Endoscopic Camera System2025-07-01
K243260 — FUJIFILM Processor EP-8000; FUJIFILM Endoscope Model EG-860R2025-04-11

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.