510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K925361Substantially Equivalent

Biopsy Forceps, Electric

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

K925361 is the FDA 510(k) clearance record for BIOPSY FORCEPS, ELECTRIC, a class II device, cleared for United States Endoscopy Group, Inc. on under FDA product code KGE (Forceps, Biopsy, Electric). FDA records list 94 510(k) clearances for United States Endoscopy Group, Inc., from to . As of , FDA records show no recalls naming K925361.

Clearance record

Decision date
Received
(158 days to decision)
Product code
KGE Forceps, Biopsy, Electric
Regulation
21 CFR 876.4300
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
United States Endoscopy Group, Inc. 7123 Industrial Park Blvd., Mentor OH
510(k) summary
Statement
Third party review
No

Clearances, product code KGE

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