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FDA 510(k)

MERTEX-PLUS REUSABLE SURGICAL DRAPE

K-Number: K012237 · 2001-10-15

ApplicantMercan AB
Decision Date2001-10-15
Product CodeKKX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MERTEX-PLUS REUSABLE SURGICAL DRAPE is the device name listed in this FDA 510(k) record. The listed applicant is Mercan AB. It received FDA 510(k) clearance on 2001-10-15 under 510(k) number K012237. 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 MERTEX-PLUS REUSABLE SURGICAL DRAPE?

MERTEX-PLUS REUSABLE SURGICAL DRAPE is a medical device that received FDA 510(k) clearance on 2001-10-15. The listed applicant is Mercan AB. The 510(k) number is K012237.

When did MERTEX-PLUS REUSABLE SURGICAL DRAPE receive FDA 510(k) clearance?

MERTEX-PLUS REUSABLE SURGICAL DRAPE received FDA 510(k) clearance on 2001-10-15, under 510(k) number K012237.

Who is the listed applicant for MERTEX-PLUS REUSABLE SURGICAL DRAPE?

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

What is the FDA product code for MERTEX-PLUS REUSABLE SURGICAL DRAPE?

The FDA product code for MERTEX-PLUS REUSABLE 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 Mercan AB 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.

K012240MERTEX-PLUS O.R./SURGEONS GOWN, NONSTERILE

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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