510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K924103Substantially Equivalent

Cleaning Brush

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

K924103 is the FDA 510(k) clearance record for CLEANING BRUSH, a class II device, cleared for United States Endoscopy Group, Inc. on under FDA product code FEB (Accessories, Cleaning, For Endoscope). FDA's definition for product code FEB reads: "If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at...". FDA records list 94 510(k) clearances for United States Endoscopy Group, Inc., from to . As of , FDA records show no recalls naming K924103.

Clearance record

Decision date
Received
(95 days to decision)
Product code
FEB Accessories, Cleaning, For Endoscope
Regulation
21 CFR 876.1500
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
United States Endoscopy Group, Inc. 9905 Hobart Rd., Waite Hill OH
510(k) summary
Statement
Third party review
No

Clearances, product code FEB

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