FDA 510(k)

RENASYS F/-AB ABDOMINAL WOUND DRESSING KIT

K-Number: K100787 · 2010-09-17

Decision Date2010-09-17

Product CodeFTL

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

RENASYS F/-AB ABDOMINAL WOUND 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 2010-09-17 under 510(k) number K100787. 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 F/-AB ABDOMINAL WOUND DRESSING KIT?

RENASYS F/-AB ABDOMINAL WOUND DRESSING KIT is a medical device that received FDA 510(k) clearance on 2010-09-17. The listed applicant is Smith & Nephew, Inc.. The 510(k) number is K100787.

When did RENASYS F/-AB ABDOMINAL WOUND DRESSING KIT receive FDA 510(k) clearance?

RENASYS F/-AB ABDOMINAL WOUND DRESSING KIT received FDA 510(k) clearance on 2010-09-17, under 510(k) number K100787.

Who is the listed applicant for RENASYS F/-AB ABDOMINAL WOUND 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 F/-AB ABDOMINAL WOUND DRESSING KIT?

The FDA product code for RENASYS F/-AB ABDOMINAL WOUND 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.