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FDA 510(k)

SURGICAL PROCEDURE PACKS

K-Number: K110724 · 2011-06-23

ApplicantOmnia Spa
Decision Date2011-06-23
Product CodeFYA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SURGICAL PROCEDURE PACKS is the device name listed in this FDA 510(k) record. The listed applicant is Omnia Spa. It received FDA 510(k) clearance on 2011-06-23 under 510(k) number K110724. 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 PROCEDURE PACKS?

SURGICAL PROCEDURE PACKS is a medical device that received FDA 510(k) clearance on 2011-06-23. The listed applicant is Omnia Spa. The 510(k) number is K110724.

When did SURGICAL PROCEDURE PACKS receive FDA 510(k) clearance?

SURGICAL PROCEDURE PACKS received FDA 510(k) clearance on 2011-06-23, under 510(k) number K110724.

Who is the listed applicant for SURGICAL PROCEDURE PACKS?

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

What is the FDA product code for SURGICAL PROCEDURE PACKS?

The FDA product code for SURGICAL PROCEDURE PACKS 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 Omnia Spa 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.

K180630PTFE SURGICAL SUTURE

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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