FDA 510(k)

RENASYS AB ABOMINAL DRESSING KIT

K-Number: K112784 · 2011-11-22

Decision Date2011-11-22

Product CodeFTL

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

RENASYS AB ABOMINAL DRESSING KIT 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 2011-11-22 under 510(k) number K112784. The device is classified under product code FTL. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RENASYS AB ABOMINAL DRESSING KIT?

RENASYS AB ABOMINAL DRESSING KIT is a medical device that received FDA 510(k) clearance on 2011-11-22. The listed applicant is Smith & Nephew, Inc.. The 510(k) number is K112784.

When did RENASYS AB ABOMINAL DRESSING KIT receive FDA 510(k) clearance?

RENASYS AB ABOMINAL DRESSING KIT received FDA 510(k) clearance on 2011-11-22, under 510(k) number K112784.

Who is the listed applicant for RENASYS AB ABOMINAL DRESSING KIT?

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 AB ABOMINAL DRESSING KIT?

The FDA product code for RENASYS AB ABOMINAL DRESSING KIT is FTL.

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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.