Cleared Special

K112784 - RENASYS AB ABOMINAL DRESSING KIT

K112784 is an FDA 510(k) clearance for RENASYS AB ABOMINAL DRESSING KIT, manufactured by Smith & Nephew, Inc.. The device is a Class 2 General & Plastic Surgery device with product code FTL cleared through the Special 510(k) pathway after a 57-day FDA review.

K112784 · Smith & Nephew, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2011
Decision
57d
Days
Class 2
Risk

K112784 is an FDA 510(k) clearance for the RENASYS AB ABOMINAL DRESSING KIT. Classified as Mesh, Surgical, Polymeric (product code FTL), Class II - Special Controls.

Submitted by Smith & Nephew, Inc. (St Petersburg, US). The FDA issued a Cleared decision on November 22, 2011 after a review of 57 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.3300 - the FDA general and plastic surgery device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K112784

510(k) Number K112784 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 26, 2011
Decision Date November 22, 2011
Days to Decision 57 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
58d faster than avg
Panel avg: 115d · This submission: 57d
Pathway characteristics
Modification to existing cleared device.

FTL Device Classification - Class 2, Special Controls

Product Code FTL Mesh, Surgical, Polymeric
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.3300
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - FTL Mesh, Surgical, Polymeric

All 336
Devices cleared under the same product code (FTL) and FDA review panel - the closest regulatory comparables to K112784.
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K112784 · RENASYS AB ABOMINAL DRESSING KIT
Download PDF FDA Summary Smith & Nephew, Inc.