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FDA 510(k)

SURGICAL CONCEPT DESIGNS POSITIONOR SURGICAL DRAPE

K-Number: K081476 · 2008-08-08

ApplicantSurgical Concept Designs
Decision Date2008-08-08
Product CodeKKX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SURGICAL CONCEPT DESIGNS POSITIONOR SURGICAL DRAPE is the device name listed in this FDA 510(k) record. The listed applicant is Surgical Concept Designs. It received FDA 510(k) clearance on 2008-08-08 under 510(k) number K081476. 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 CONCEPT DESIGNS POSITIONOR SURGICAL DRAPE?

SURGICAL CONCEPT DESIGNS POSITIONOR SURGICAL DRAPE is a medical device that received FDA 510(k) clearance on 2008-08-08. The listed applicant is Surgical Concept Designs. The 510(k) number is K081476.

When did SURGICAL CONCEPT DESIGNS POSITIONOR SURGICAL DRAPE receive FDA 510(k) clearance?

SURGICAL CONCEPT DESIGNS POSITIONOR SURGICAL DRAPE received FDA 510(k) clearance on 2008-08-08, under 510(k) number K081476.

Who is the listed applicant for SURGICAL CONCEPT DESIGNS POSITIONOR SURGICAL DRAPE?

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

What is the FDA product code for SURGICAL CONCEPT DESIGNS POSITIONOR SURGICAL DRAPE?

The FDA product code for SURGICAL CONCEPT DESIGNS POSITIONOR SURGICAL DRAPE 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

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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