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FDA 510(k)

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

K-Number: K210342 · 2021-09-03

ApplicantSTERIS Corporation
Decision Date2021-09-03
Product CodeODC
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

BioShield- ERCP Biopsy Valve, BioShield Irrigator - Extension Tubing, BioShield Irrigating Adaptor is a medical device manufactured by STERIS Corporation. It received FDA 510(k) clearance on 2021-09-03 under approval number K210342. The device is classified under product code ODC. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BioShield- ERCP Biopsy Valve, BioShield Irrigator - Extension Tubing, BioShield Irrigating Adaptor?

BioShield- ERCP Biopsy Valve, BioShield Irrigator - Extension Tubing, BioShield Irrigating Adaptor is a medical device that received FDA 510(k) clearance on 2021-09-03. It is manufactured by STERIS Corporation. The 510(k) number is K210342.

When was BioShield- ERCP Biopsy Valve, BioShield Irrigator - Extension Tubing, BioShield Irrigating Adaptor approved by the FDA?

BioShield- ERCP Biopsy Valve, BioShield Irrigator - Extension Tubing, BioShield Irrigating Adaptor received FDA 510(k) clearance on 2021-09-03, under approval number K210342.

What company makes BioShield- ERCP Biopsy Valve, BioShield Irrigator - Extension Tubing, BioShield Irrigating Adaptor?

BioShield- ERCP Biopsy Valve, BioShield Irrigator - Extension Tubing, BioShield Irrigating Adaptor is manufactured by STERIS Corporation.

What is the FDA product code for BioShield- ERCP Biopsy Valve, BioShield Irrigator - Extension Tubing, BioShield Irrigating Adaptor?

The FDA product code for BioShield- ERCP Biopsy Valve, BioShield Irrigator - Extension Tubing, BioShield Irrigating Adaptor is ODC.

Related Clinical Trials

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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.

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