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FDA 510(k)

SURGICAL GOWN, REINFORCED

K-Number: K772182 · 1977-12-08

ApplicantSurgikos, Inc.
Decision Date1977-12-08
Product CodeFYA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SURGICAL GOWN, REINFORCED is the device name listed in this FDA 510(k) record. The listed applicant is Surgikos, Inc.. It received FDA 510(k) clearance on 1977-12-08 under 510(k) number K772182. 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 SURGICAL GOWN, REINFORCED?

SURGICAL GOWN, REINFORCED is a medical device that received FDA 510(k) clearance on 1977-12-08. The listed applicant is Surgikos, Inc.. The 510(k) number is K772182.

When did SURGICAL GOWN, REINFORCED receive FDA 510(k) clearance?

SURGICAL GOWN, REINFORCED received FDA 510(k) clearance on 1977-12-08, under 510(k) number K772182.

Who is the listed applicant for SURGICAL GOWN, REINFORCED?

The FDA 510(k) record lists Surgikos, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SURGICAL GOWN, REINFORCED?

The FDA product code for SURGICAL GOWN, REINFORCED is FYA.

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Other records listing Surgikos, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K875107HEALTH CARE EYE PROTECTIONK874653STERILE SURGICAL SCRUB BRUSHK861441NEUTRALON SURGICAL GLOVESK852870BARRIER SURGICAL GOWNK822535CIDEX*DIALYZER DISINFECTING SOLUTIONK820543BARRIER ANTIMICROBIAL INCISE DRAPE

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Related Devices (Code: FYA)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260407Principle & Will ANSI/AAMI PB 70 (Sterile/Non-sterile) Level 3 Surgical Gowns (Reinforced) and Principle & Will ANSI/AMMI PB70 (Sterile/Non-sterile) Level 4 Surgical Gowns/Isolation GownsPrinciple & Will Co., Ltd.K261028Surgical Gown Level2 (S, M, L, XL, XXL, XXXL)Yadu Medical (Henan) Co., Ltd.K261949NYES Tuff Cuff L3 Disposable GownsNew York Embroidery StudioK252575Tuff 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

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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