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FDA 510(k)

Seal Single Use Biopsy Valve

K-Number: K182275 · 2018-09-13

ApplicantBoston Scientific Corporation
Decision Date2018-09-13
Product CodeOCX
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Seal Single Use Biopsy Valve is a medical device manufactured by Boston Scientific Corporation. It received FDA 510(k) clearance on 2018-09-13 under approval number K182275. The device is classified under product code OCX. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Seal Single Use Biopsy Valve?

Seal Single Use Biopsy Valve is a medical device that received FDA 510(k) clearance on 2018-09-13. It is manufactured by Boston Scientific Corporation. The 510(k) number is K182275.

When was Seal Single Use Biopsy Valve approved by the FDA?

Seal Single Use Biopsy Valve received FDA 510(k) clearance on 2018-09-13, under approval number K182275.

What company makes Seal Single Use Biopsy Valve?

Seal Single Use Biopsy Valve is manufactured by Boston Scientific Corporation.

What is the FDA product code for Seal Single Use Biopsy Valve?

The FDA product code for Seal Single Use Biopsy Valve is OCX.

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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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