FDA 510(k)

MODIFICATION TO RENASYS EZ PLUS NEGATIVE PRESSURE WOUND THERAPY

K-Number: K102001 · 2010-08-06

Decision Date2010-08-06

Product CodeOMP

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO RENASYS EZ PLUS NEGATIVE PRESSURE WOUND THERAPY 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 2010-08-06 under 510(k) number K102001. 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 MODIFICATION TO RENASYS EZ PLUS NEGATIVE PRESSURE WOUND THERAPY?

MODIFICATION TO RENASYS EZ PLUS NEGATIVE PRESSURE WOUND THERAPY is a medical device that received FDA 510(k) clearance on 2010-08-06. The listed applicant is Smith & Nephew, Inc.. The 510(k) number is K102001.

When did MODIFICATION TO RENASYS EZ PLUS NEGATIVE PRESSURE WOUND THERAPY receive FDA 510(k) clearance?

MODIFICATION TO RENASYS EZ PLUS NEGATIVE PRESSURE WOUND THERAPY received FDA 510(k) clearance on 2010-08-06, under 510(k) number K102001.

Who is the listed applicant for MODIFICATION TO RENASYS EZ PLUS NEGATIVE PRESSURE WOUND THERAPY?

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 MODIFICATION TO RENASYS EZ PLUS NEGATIVE PRESSURE WOUND THERAPY?

The FDA product code for MODIFICATION TO RENASYS EZ PLUS NEGATIVE PRESSURE WOUND THERAPY is 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.