BioShield Biopsy Valve EUS - Linear

Endoscopic Retrograde Cholangiopancreatography (ercp) Cannula

Steris Corporation

The following data is part of a premarket notification filed by Steris Corporation with the FDA for Bioshield Biopsy Valve Eus - Linear.

Pre-market Notification Details

Device IDK202583
510k NumberK202583
Device Name:BioShield Biopsy Valve EUS - Linear
ClassificationEndoscopic Retrograde Cholangiopancreatography (ercp) Cannula
Applicant Steris Corporation 5976 Heisley Rd Mentor,  OH  44060
ContactJacqueline Oliver
CorrespondentJacqueline Oliver
Steris Corporation 5976 Heisley Rd Mentor,  OH  44060
Product CodeODD  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-09-08
Decision Date2020-11-06

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.