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FDA 510(k)

SURGICAL DRAPES

K-Number: K061422 · 2006-09-25

ApplicantAustin Medical, Inc.
Decision Date2006-09-25
Product CodeKKX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SURGICAL DRAPES is the device name listed in this FDA 510(k) record. The listed applicant is Austin Medical, Inc.. It received FDA 510(k) clearance on 2006-09-25 under 510(k) number K061422. The device is classified under product code KKX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SURGICAL DRAPES?

SURGICAL DRAPES is a medical device that received FDA 510(k) clearance on 2006-09-25. The listed applicant is Austin Medical, Inc.. The 510(k) number is K061422.

When did SURGICAL DRAPES receive FDA 510(k) clearance?

SURGICAL DRAPES received FDA 510(k) clearance on 2006-09-25, under 510(k) number K061422.

Who is the listed applicant for SURGICAL DRAPES?

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

What is the FDA product code for SURGICAL DRAPES?

The FDA product code for SURGICAL DRAPES is KKX.

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Related Devices (Code: KKX)

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.

K230645BeneHold™ Surgical Incise Drape with CHG antimicrobial IIAvery Dennison Medical , Ltd.K2225783M™ Ioban™ CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG)3M CompanyK202208BeneHold Surgical Incise Drape with CHG antimicrobialAvery Dennison Belgie BvbaK200238ControlRad Sterile CoverControlrad, Inc.K163556MediClear PreOpCovalontechnologies, Inc.K130404TIBURON SURGICAL DRAPECardinal Health200, 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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