About This 510(k) Submission
K250462 is an FDA 510(k) clearance for the UL UHD-Clear View 4K Camera System (UL-3Chip 4K), 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 review panel. Regulated under 21 CFR 876.1500.