Cleared Traditional

K100787 - RENASYS F/-AB ABDOMINAL WOUND DRESSING KIT

K100787 is the FDA 510(k) clearance for RENASYS F/-AB ABDOMINAL WOUND DRESSING KIT by Smith & Nephew, Inc.. It is a Class 2 General & Plastic Surgery device (product code FTL) cleared through the Traditional 510(k) pathway after a 182-day FDA review.

K100787 · Smith & Nephew, Inc. · General & Plastic Surgery device
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Sep 2010
Decision
182d
Days
Class 2
Risk

K100787 is an FDA 510(k) clearance for the RENASYS F/-AB ABDOMINAL WOUND 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 September 17, 2010 after a review of 182 days - an extended review 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Smith & Nephew, Inc. devices

Submission Details

510(k) Number K100787 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 19, 2010
Decision Date September 17, 2010
Days to Decision 182 days
Submission Type Traditional
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
67d slower than avg
Panel avg: 115d · This submission: 182d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 185
Devices cleared under the same product code (FTL) and FDA review panel - the closest regulatory comparables to K100787.
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PARIE TENE PROGRIP MESH
K101197 · Sofradim Production · May 2010
TORNIER SURGICAL MESH
K093799 · Tornier, Inc. · Apr 2010
VENTRIO HERNIA PATCH
K100229 · C.R. Bard, Inc. · Apr 2010