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510(k) K250462

UL UHD-Clear View 4K Camera System (UL-3Chip 4K) by Univlabs Technologies Private Limited — Product Code FET

K250462 is an FDA 510(k) premarket notification submitted by Univlabs Technologies Private Limited for the device "UL UHD-Clear View 4K Camera System (UL-3Chip 4K)". The FDA issued a decision of Substantially Equivalent on August 11, 2025. The device falls under product code FET (Endoscopic Video Imaging System/Component, Gastroenterology-Urology), a Class II device regulated under 21 CFR 876.1500.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 11, 2025
Date Received
February 18, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Endoscopic Video Imaging System/Component, Gastroenterology-Urology
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type

To allow for visualization of body cavities through an endoscope by projecting images to a monitor.

Other clearances for product code FET

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  • K251734 — ProVee Video Processing Unit (PV-003) (September 24, 2025)
  • K250204 — Endoscopic Camera System (July 1, 2025)
  • K243260 — FUJIFILM Processor EP-8000; FUJIFILM Endoscope Model EG-860R (April 11, 2025)
  • K242067 — VISERA ELITE III VIDEO SYSTEM CENTER OLYMPUS OTV-S700; VISERA ELITE III LED LIGH (April 2, 2025)
  • K243321 — Endoscopic Video Image Processor (RP-IPD-V1000F) (February 7, 2025)
  • K241532 — Flexible Video-Choledo-Cysto-Ureteroscope System (PL-2100) (October 22, 2024)
  • K241371 — VISERA S VIDEO SYSTEM CENTER OLYMPUS OTV-S500 (OLYMPUS OTV-S500) (July 3, 2024)
  • K222584 — EVIS X1 VIDEO SYSTEM CENTER OLYMPUS CV-1500, COLONOVIDEOSCOPE OLYMPUS CF-HQ1100D (April 26, 2023)

FDA data resources