510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K911485Substantially Equivalent

Color Video Camera

United States Endoscopy Group, Inc., Mentor OH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K911485 is the FDA 510(k) clearance record for COLOR VIDEO CAMERA, a class II device, cleared for United States Endoscopy Group, Inc. on under FDA product code FET (Endoscopic Video Imaging System/Component, Gastroenterology-Urology). FDA's definition for product code FET reads: "To allow for visualization of body cavities through an endoscope by projecting images to a monitor". FDA records list 94 510(k) clearances for United States Endoscopy Group, Inc., from to . As of , FDA records show no recalls naming K911485.

Clearance record

Decision date
Received
(132 days to decision)
Product code
FET Endoscopic Video Imaging System/Component, Gastroenterology-Urology
Regulation
21 CFR 876.1500
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
United States Endoscopy Group, Inc. 7123 Industrial Park Blvd., Mentor OH
Third party review
No

Clearances, product code FET

Trailing 12 months
3 clearances under product code FET in the twelve months to November 2026, June 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code FET, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20261
July 20261
August 20260
September 20261
October 20260
November 20260