510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K210342Substantially Equivalent

BioShield- ERCP Biopsy Valve, BioShield Irrigator - Extension Tubing, BioShield Irrigating Adaptor

STERIS Corporation, Mentor OH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K210342 is the FDA 510(k) clearance record for BioShield- ERCP Biopsy Valve, BioShield Irrigator - Extension Tubing, BioShield Irrigating Adaptor, a class II device, cleared for STERIS Corporation 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 227 510(k) clearances for STERIS Corporation, from to . As of , FDA records show no recalls naming K210342.

Clearance record

Decision date
Received
(210 days to decision)
Product code
ODC Endoscope Channel Accessory
Regulation
21 CFR 876.1500
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
STERIS Corporation 5976 Heisley Rd., Mentor OH
510(k) summary
Summary PDF
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