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FDA 510(k)

KCI NPWT GAUZE DRESSING

K-Number: K123507 · 2013-04-04

ApplicantKci USA, Inc.
Decision Date2013-04-04
Product CodeOMP
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

KCI NPWT GAUZE DRESSING is the device name listed in this FDA 510(k) record. The listed applicant is Kci USA, Inc.. It received FDA 510(k) clearance on 2013-04-04 under 510(k) number K123507. The device is classified under product code OMP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KCI NPWT GAUZE DRESSING?

KCI NPWT GAUZE DRESSING is a medical device that received FDA 510(k) clearance on 2013-04-04. The listed applicant is Kci USA, Inc.. The 510(k) number is K123507.

When did KCI NPWT GAUZE DRESSING receive FDA 510(k) clearance?

KCI NPWT GAUZE DRESSING received FDA 510(k) clearance on 2013-04-04, under 510(k) number K123507.

Who is the listed applicant for KCI NPWT GAUZE DRESSING?

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

What is the FDA product code for KCI NPWT GAUZE DRESSING?

The FDA product code for KCI NPWT GAUZE DRESSING is OMP.

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Related Devices (Code: OMP)

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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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