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FDA 510(k)

FREEDOM MARK III SURGICAL HELMET SYSTEM

K-Number: K910515 · 1991-05-06

ApplicantStackhouse Assoc.
Decision Date1991-05-06
Product CodeFYA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

FREEDOM MARK III SURGICAL HELMET SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Stackhouse Assoc.. It received FDA 510(k) clearance on 1991-05-06 under 510(k) number K910515. 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 FREEDOM MARK III SURGICAL HELMET SYSTEM?

FREEDOM MARK III SURGICAL HELMET SYSTEM is a medical device that received FDA 510(k) clearance on 1991-05-06. The listed applicant is Stackhouse Assoc.. The 510(k) number is K910515.

When did FREEDOM MARK III SURGICAL HELMET SYSTEM receive FDA 510(k) clearance?

FREEDOM MARK III SURGICAL HELMET SYSTEM received FDA 510(k) clearance on 1991-05-06, under 510(k) number K910515.

Who is the listed applicant for FREEDOM MARK III SURGICAL HELMET SYSTEM?

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

What is the FDA product code for FREEDOM MARK III SURGICAL HELMET SYSTEM?

The FDA product code for FREEDOM MARK III SURGICAL HELMET SYSTEM is FYA.

Related Clinical Trials

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Other records listing Stackhouse Assoc. 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.

K912651AIRSAFE MINIVAC SMOKE FILTRATION SYSTEMK874512MODIFIED BIOVAC:LFA LASER FUME EVACUATION SYSTEMK872935ANTI-INFECTION SHIELDK790877BIOVAC: LFA LASER FUME (SMOKE) EVACUATIO

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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