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FDA 510(k)

EndoArmor™ + Surgical Gown

K-Number: K203548 · 2022-02-21

ApplicantBoston Scientific Corporation
Decision Date2022-02-21
Product CodeFYA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

EndoArmor™ + Surgical Gown is a medical device manufactured by Boston Scientific Corporation. It received FDA 510(k) clearance on 2022-02-21 under approval number K203548. The device is classified under product code FYA. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EndoArmor™ + Surgical Gown?

EndoArmor™ + Surgical Gown is a medical device that received FDA 510(k) clearance on 2022-02-21. It is manufactured by Boston Scientific Corporation. The 510(k) number is K203548.

When was EndoArmor™ + Surgical Gown approved by the FDA?

EndoArmor™ + Surgical Gown received FDA 510(k) clearance on 2022-02-21, under approval number K203548.

What company makes EndoArmor™ + Surgical Gown?

EndoArmor™ + Surgical Gown is manufactured by Boston Scientific Corporation.

What is the FDA product code for EndoArmor™ + Surgical Gown?

The FDA product code for EndoArmor™ + Surgical Gown is FYA.

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Related Devices (Code: FYA)

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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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