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FDA 510(k)

WOUND PRO APEX

K-Number: K100823 · 2011-01-24

ApplicantAccuro Medical Products, LLC
Decision Date2011-01-24
Product CodeOMP
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

WOUND PRO APEX is the device name listed in this FDA 510(k) record. The listed applicant is Accuro Medical Products, LLC. It received FDA 510(k) clearance on 2011-01-24 under 510(k) number K100823. 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 WOUND PRO APEX?

WOUND PRO APEX is a medical device that received FDA 510(k) clearance on 2011-01-24. The listed applicant is Accuro Medical Products, LLC. The 510(k) number is K100823.

When did WOUND PRO APEX receive FDA 510(k) clearance?

WOUND PRO APEX received FDA 510(k) clearance on 2011-01-24, under 510(k) number K100823.

Who is the listed applicant for WOUND PRO APEX?

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

What is the FDA product code for WOUND PRO APEX?

The FDA product code for WOUND PRO APEX is OMP.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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