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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is STERIS Corporation. It received FDA 510(k) clearance on 2020-11-06 under 510(k) 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. The listed applicant is STERIS Corporation. The 510(k) number is K202583.

When did BioShield biopsy valve EUS - Linear receive FDA 510(k) clearance?

BioShield biopsy valve EUS - Linear received FDA 510(k) clearance on 2020-11-06, under 510(k) number K202583.

Who is the listed applicant for BioShield biopsy valve EUS - Linear?

The FDA 510(k) record lists STERIS Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BioShield biopsy valve EUS - Linear?

The FDA product code for BioShield biopsy valve EUS - Linear is ODD.

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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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