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FDA 510(k)

MICROTEK EQUIPMENT DRAPES

K-Number: K050322 · 2005-05-17

ApplicantMicrotek Medical, Inc.
Decision Date2005-05-17
Product CodeKKX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MICROTEK EQUIPMENT DRAPES is the device name listed in this FDA 510(k) record. The listed applicant is Microtek Medical, Inc.. It received FDA 510(k) clearance on 2005-05-17 under 510(k) number K050322. 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 MICROTEK EQUIPMENT DRAPES?

MICROTEK EQUIPMENT DRAPES is a medical device that received FDA 510(k) clearance on 2005-05-17. The listed applicant is Microtek Medical, Inc.. The 510(k) number is K050322.

When did MICROTEK EQUIPMENT DRAPES receive FDA 510(k) clearance?

MICROTEK EQUIPMENT DRAPES received FDA 510(k) clearance on 2005-05-17, under 510(k) number K050322.

Who is the listed applicant for MICROTEK EQUIPMENT DRAPES?

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

What is the FDA product code for MICROTEK EQUIPMENT DRAPES?

The FDA product code for MICROTEK EQUIPMENT DRAPES is KKX.

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Other records listing Microtek Medical, Inc. 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.

K110358VENODYNE V810K102971FREEDOMAIRE III SURGICAL HELMET SYSTEM MODEL 10322STKK062899MICROTEK MEDICAL SURGICAL GOWN/TOGAK060200MICROTEK MEDICAL WARMING DRAPEK022903CHILLBUSTERK020956VIVOSONIC DIANOSTIC ULTRASOUND IMAGING COUPLING MEDIA

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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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