510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K151345Substantially Equivalent

BioGuard Air/Water Valve, BioGuard Suction Valve

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

K151345 is the FDA 510(k) clearance record for BioGuard Air/Water Valve, BioGuard Suction Valve, a class II device, cleared for United States Endoscopy Group, Inc. on under FDA product code ODC (Endoscope Channel Accessory). FDA's definition for product code ODC reads: "To give the endoscope channel additional or improved functionality". FDA records list 94 510(k) clearances for United States Endoscopy Group, Inc., from to . As of , FDA records show no recalls naming K151345.

Clearance record

Decision date
Received
(98 days to decision)
Product code
ODC Endoscope Channel Accessory
Regulation
21 CFR 876.1500
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
United States Endoscopy Group, Inc. 5976 Heisley Rd., Mentor OH
510(k) summary
Statement
Third party review
No

Clearances, product code ODC

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