FDA 510(k)

EndoArmor™ + Surgical Gown

K-Number: K203548 · 2022-02-21

Decision Date2022-02-21

Product CodeFYA

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

EndoArmor™ + Surgical Gown is the device name listed in this FDA 510(k) record. The listed applicant is Boston Scientific Corporation. It received FDA 510(k) clearance on 2022-02-21 under 510(k) 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. The listed applicant is Boston Scientific Corporation. The 510(k) number is K203548.

When did EndoArmor™ + Surgical Gown receive FDA 510(k) clearance?

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

Who is the listed applicant for EndoArmor™ + Surgical Gown?

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

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)

K261028Surgical Gown Level2 (S, M, L, XL, XXL, XXXL)Yadu Medical (Henan) Co., Ltd.K261949NYES Tuff Cuff L3 Disposable GownsNew York Embroidery Studio K252575Tuff Cuff™ Disposable Surgical Gowns AAMI L4 Sterile-Large (ML-L4-STL-DC-L)New York Embroidery Studio (NYES)K260725BAÜMER Surgical Gowns (COP01, COP04, COP05, COP10)Hindernis DE Mexico, S.A.P.I. DE C.V.K253243Cardinal Health™ Poly Reinforced Surgical GownCardinal Health 200, LLC K253003Non-sterile Level 3 Surgical Gown (4025); Sterile Level 3 Surgical Gown (M4025); Non-sterile Reinforced Level 4 Surgical Gown (G4025); Reinforced Sterile Level 4 Surgical Gown (GM4025)Hubei Xinxin Non-Woven Co., Ltd.

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.