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FDA 510(k)

Banyan USA Surgical Mask Level 3

K-Number: K211097 · 2021-09-22

ApplicantBanyan USA, LLC
Decision Date2021-09-22
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Banyan USA Surgical Mask Level 3 is a medical device manufactured by Banyan USA, LLC. It received FDA 510(k) clearance on 2021-09-22 under approval number K211097. The device is classified under product code FXX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Banyan USA Surgical Mask Level 3?

Banyan USA Surgical Mask Level 3 is a medical device that received FDA 510(k) clearance on 2021-09-22. It is manufactured by Banyan USA, LLC. The 510(k) number is K211097.

When was Banyan USA Surgical Mask Level 3 approved by the FDA?

Banyan USA Surgical Mask Level 3 received FDA 510(k) clearance on 2021-09-22, under approval number K211097.

What company makes Banyan USA Surgical Mask Level 3?

Banyan USA Surgical Mask Level 3 is manufactured by Banyan USA, LLC.

What is the FDA product code for Banyan USA Surgical Mask Level 3?

The FDA product code for Banyan USA Surgical Mask Level 3 is FXX.

Related Clinical Trials

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Related PubMed Literature

PMID: 42201559 Time-series and thematic analyses of clinical utilities and operational issues in early clinical studies of the da Vinci surgical system. Journal of robotic surgery (2026)

Related Devices (Code: FXX)

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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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