BioShield biopsy valve EUS - Linear
K-Number: K202583 · 2020-11-06
ApplicantSTERIS Corporation
Decision Date2020-11-06
Product CodeODD
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
BioShield biopsy valve EUS - Linear is a medical device manufactured by STERIS Corporation. It received FDA 510(k) clearance on 2020-11-06 under approval number K202583. The device is classified under product code ODD. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the BioShield biopsy valve EUS - Linear?
BioShield biopsy valve EUS - Linear is a medical device that received FDA 510(k) clearance on 2020-11-06. It is manufactured by STERIS Corporation. The 510(k) number is K202583.
When was BioShield biopsy valve EUS - Linear approved by the FDA?
BioShield biopsy valve EUS - Linear received FDA 510(k) clearance on 2020-11-06, under approval number K202583.
What company makes BioShield biopsy valve EUS - Linear?
BioShield biopsy valve EUS - Linear is manufactured by STERIS Corporation.
What is the FDA product code for BioShield biopsy valve EUS - Linear?
The FDA product code for BioShield biopsy valve EUS - Linear is ODD.
Other Devices by STERIS Corporation
Related Devices (Code: ODD)
K171989Classic ERCP Catheter and Huibregtse-Katon ERCP Catheter and Huibregtse-Katon Angled, Glo-Tip ERCP Catheter, Glo-Tip II Double Lumen ERCP Catheter & w/ Radiopaque Bands, Fusion ERCP Catheter with DomeTip and Fusion OMNI ERCP Catheter with DomeTip, Haber RAMP Catheter, Soehendra Universal CatheterWilson-Cook Medical, Inc.
K250573Single Use Cannula V PR-V223Q/V414Q/V416Q/V418Q/V420Q/V427Q/V434Q/V435Q; Single Use 2-Lumen Cannula V PR-V614MOlympus Medical Systems Corp.
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.