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)

OMNIMED SURGICAL GOWN

K-Number: K851938 · 1985-06-28

ApplicantOmni Intl., Inc.
Decision Date1985-06-28
Product CodeFYA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

OMNIMED SURGICAL GOWN is the device name listed in this FDA 510(k) record. The listed applicant is Omni Intl., Inc.. It received FDA 510(k) clearance on 1985-06-28 under 510(k) number K851938. 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 OMNIMED SURGICAL GOWN?

OMNIMED SURGICAL GOWN is a medical device that received FDA 510(k) clearance on 1985-06-28. The listed applicant is Omni Intl., Inc.. The 510(k) number is K851938.

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

OMNIMED SURGICAL GOWN received FDA 510(k) clearance on 1985-06-28, under 510(k) number K851938.

Who is the listed applicant for OMNIMED SURGICAL GOWN?

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

What is the FDA product code for OMNIMED SURGICAL GOWN?

The FDA product code for OMNIMED SURGICAL GOWN 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 Omni Intl., 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.

K984066OMNIGRIP, LATEX SURGICAL GLOVE, POWDER-FREE WITH PROTEIN LABELING CLAIMK984064OMNIGRIP, LATEX SURGICAL GLOVE, POWDER FREEK853255OMNIMED I.V. SOLUTION ADMIN. SETK851654OMNIMED CLAMPK851734OMNIMED SUPERIOR TRANSDUCER PROTECTORK850706F-SERIES IMPLANT

View all 12 devices →

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.

↑