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

Endoscope Channel Accessory

STERIS Corporation

The following data is part of a premarket notification filed by Steris Corporation with the FDA for Bioshield- Ercp Biopsy Valve, Bioshield Irrigator - Extension Tubing, Bioshield Irrigating Adaptor.

Pre-market Notification Details

Device IDK210342
510k NumberK210342
Device Name:BioShield- ERCP Biopsy Valve, BioShield Irrigator - Extension Tubing, BioShield Irrigating Adaptor
ClassificationEndoscope Channel Accessory
Applicant STERIS Corporation 5976 Heisley Rd Mentor,  OH  44060
ContactCarroll Martin
CorrespondentCarroll Martin
STERIS Corporation 5976 Heisley Rd Mentor,  OH  44060
Product CodeODC  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-02-05
Decision Date2021-09-03

© 2021 FDA.report
This site is not affiliated with or endorsed by the FDA.