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FDA 510(k)

COBES SURGICAL DRAPE

K-Number: K112378 · 2012-05-08

ApplicantCobes Industries Co., Ltd.
Decision Date2012-05-08
Product CodeKKX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

COBES SURGICAL DRAPE is the device name listed in this FDA 510(k) record. The listed applicant is Cobes Industries Co., Ltd.. It received FDA 510(k) clearance on 2012-05-08 under 510(k) number K112378. 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 COBES SURGICAL DRAPE?

COBES SURGICAL DRAPE is a medical device that received FDA 510(k) clearance on 2012-05-08. The listed applicant is Cobes Industries Co., Ltd.. The 510(k) number is K112378.

When did COBES SURGICAL DRAPE receive FDA 510(k) clearance?

COBES SURGICAL DRAPE received FDA 510(k) clearance on 2012-05-08, under 510(k) number K112378.

Who is the listed applicant for COBES SURGICAL DRAPE?

The FDA 510(k) record lists Cobes Industries Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for COBES SURGICAL DRAPE?

The FDA product code for COBES SURGICAL DRAPE is KKX.

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.

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Other records listing Cobes Industries Co., Ltd. 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.

K112796SURGICAL GOWN (EO STERILIZED)

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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