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FDA 510(k)

UPPER EXTERMITY DRAPE KIT

K-Number: K923960 · 1994-10-07

ApplicantMedikmark, Inc.
Decision Date1994-10-07
Product CodeKKX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

UPPER EXTERMITY DRAPE KIT is the device name listed in this FDA 510(k) record. The listed applicant is Medikmark, Inc.. It received FDA 510(k) clearance on 1994-10-07 under 510(k) number K923960. 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 UPPER EXTERMITY DRAPE KIT?

UPPER EXTERMITY DRAPE KIT is a medical device that received FDA 510(k) clearance on 1994-10-07. The listed applicant is Medikmark, Inc.. The 510(k) number is K923960.

When did UPPER EXTERMITY DRAPE KIT receive FDA 510(k) clearance?

UPPER EXTERMITY DRAPE KIT received FDA 510(k) clearance on 1994-10-07, under 510(k) number K923960.

Who is the listed applicant for UPPER EXTERMITY DRAPE KIT?

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

What is the FDA product code for UPPER EXTERMITY DRAPE KIT?

The FDA product code for UPPER EXTERMITY DRAPE KIT is KKX.

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Other records listing Medikmark, 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.

K953474IV START KITK921732MINOR LAP SETK921733TRACHEOSTOMY CARE TRAYK921730C-SECTION PACKK920339DRESSING CHANGE TRAYK920341LACERATION TRAYS

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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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