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FDA 510(k)

BAÜMER Surgical Gowns (COP01, COP04, COP05, COP10)

K-Number: K260725 · 2026-05-12

ApplicantHindernis DE Mexico, S.A.P.I. DE C.V.
Decision Date2026-05-12
Product CodeFYA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

BAÜMER Surgical Gowns (COP01, COP04, COP05, COP10) is a medical device manufactured by Hindernis DE Mexico, S.A.P.I. DE C.V.. It received FDA 510(k) clearance on 2026-05-12 under approval number K260725. 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 BAÜMER Surgical Gowns (COP01, COP04, COP05, COP10)?

BAÜMER Surgical Gowns (COP01, COP04, COP05, COP10) is a medical device that received FDA 510(k) clearance on 2026-05-12. It is manufactured by Hindernis DE Mexico, S.A.P.I. DE C.V.. The 510(k) number is K260725.

When was BAÜMER Surgical Gowns (COP01, COP04, COP05, COP10) approved by the FDA?

BAÜMER Surgical Gowns (COP01, COP04, COP05, COP10) received FDA 510(k) clearance on 2026-05-12, under approval number K260725.

What company makes BAÜMER Surgical Gowns (COP01, COP04, COP05, COP10)?

BAÜMER Surgical Gowns (COP01, COP04, COP05, COP10) is manufactured by Hindernis DE Mexico, S.A.P.I. DE C.V..

What is the FDA product code for BAÜMER Surgical Gowns (COP01, COP04, COP05, COP10)?

The FDA product code for BAÜMER Surgical Gowns (COP01, COP04, COP05, COP10) is 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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