FDA 510(k)

RENASYS EZ MAX NEGATIVE PRESSURE WOUND THERAPY DEVICE

K-Number: K132446 · 2013-10-23

Decision Date2013-10-23

Product CodeOMP

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

RENASYS EZ MAX NEGATIVE PRESSURE WOUND THERAPY DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Smith & Nephew, Inc.. It received FDA 510(k) clearance on 2013-10-23 under 510(k) number K132446. 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 RENASYS EZ MAX NEGATIVE PRESSURE WOUND THERAPY DEVICE?

RENASYS EZ MAX NEGATIVE PRESSURE WOUND THERAPY DEVICE is a medical device that received FDA 510(k) clearance on 2013-10-23. The listed applicant is Smith & Nephew, Inc.. The 510(k) number is K132446.

When did RENASYS EZ MAX NEGATIVE PRESSURE WOUND THERAPY DEVICE receive FDA 510(k) clearance?

RENASYS EZ MAX NEGATIVE PRESSURE WOUND THERAPY DEVICE received FDA 510(k) clearance on 2013-10-23, under 510(k) number K132446.

Who is the listed applicant for RENASYS EZ MAX NEGATIVE PRESSURE WOUND THERAPY DEVICE?

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

What is the FDA product code for RENASYS EZ MAX NEGATIVE PRESSURE WOUND THERAPY DEVICE?

The FDA product code for RENASYS EZ MAX NEGATIVE PRESSURE WOUND THERAPY DEVICE 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.