Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

SURGEON'S GOWN

K-Number: K920404 · 1992-08-18

ApplicantAmsco Sterile Recoveries, Inc.
Decision Date1992-08-18
Product CodeFYC
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SURGEON'S GOWN is the device name listed in this FDA 510(k) record. The listed applicant is Amsco Sterile Recoveries, Inc.. It received FDA 510(k) clearance on 1992-08-18 under 510(k) number K920404. The device is classified under product code FYC. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SURGEON'S GOWN?

SURGEON'S GOWN is a medical device that received FDA 510(k) clearance on 1992-08-18. The listed applicant is Amsco Sterile Recoveries, Inc.. The 510(k) number is K920404.

When did SURGEON'S GOWN receive FDA 510(k) clearance?

SURGEON'S GOWN received FDA 510(k) clearance on 1992-08-18, under 510(k) number K920404.

Who is the listed applicant for SURGEON'S GOWN?

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

What is the FDA product code for SURGEON'S GOWN?

The FDA product code for SURGEON'S GOWN is FYC.

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 Amsco Sterile Recoveries, 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.

K932522AMSCO STERILE RECOVERIES SURGICAL PACKSK931143AMSCO STERILE RECOVERIES ABSORBENT TOWELSK931146SURGICAL DRAPES, MODIFICATIONK931145NON-STERILE ISOLATION GOWNK931144STERILE SURGEON'S GOWN, MODIFICATIONK931875AUTOCLAVABLE REUSABLE WRAP -- CENTERAL SERVICE USE

View all 12 devices →

Related Devices (Code: FYC)

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.

K232849Halyard Tri-Layer AAMI 3 Isolation Gown, L, Blue (54310), Halyard Tri-Layer AAMI 3 Isolation Gown, X-Large, Blue (54311)Owens & Minor (O&M) Halyard, Inc.K230135Copioumed Chemotherapy Isolation GownCopioumed International, Inc.K223467Disposable Isolation GownNanning Tecbod Biological Technology Co., Ltd.K223304Disposable Isolation Gowns (S,M,L,XL,XXL,XXXL)Xiamen Probtain Medical Technology Co., Ltd.K223411Disposable Isolation Gowns (S,M,L,XL,XXL,XXXL)Xiamen Probtain Medical Techology Co., Ltd.K212717Paneffort AAMI Level 3 Isolation GownPaneffort, 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.

↑