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FDA 510(k)

STERILE SUGICAL GOWN PACK

K-Number: K914563 · 1992-01-10

ApplicantAssured Surgical Products, Inc.
Decision Date1992-01-10
Product CodeFYA
Advisory CommitteeSU
DecisionUnknown

Device Summary

STERILE SUGICAL GOWN PACK is the device name listed in this FDA 510(k) record. The listed applicant is Assured Surgical Products, Inc.. It received FDA 510(k) clearance on 1992-01-10 under 510(k) number K914563. The device is classified under product code FYA. It was reviewed by the SU advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the STERILE SUGICAL GOWN PACK?

STERILE SUGICAL GOWN PACK is a medical device that received FDA 510(k) clearance on 1992-01-10. The listed applicant is Assured Surgical Products, Inc.. The 510(k) number is K914563.

When did STERILE SUGICAL GOWN PACK receive FDA 510(k) clearance?

STERILE SUGICAL GOWN PACK received FDA 510(k) clearance on 1992-01-10, under 510(k) number K914563.

Who is the listed applicant for STERILE SUGICAL GOWN PACK?

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

What is the FDA product code for STERILE SUGICAL GOWN PACK?

The FDA product code for STERILE SUGICAL GOWN PACK is FYA.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Assured Surgical Products, 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.

K914605MULTIPLE STERILE SURGICAL DRAPE PACK

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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