Cleared Special

K082216 - TBD ETHICON MESH

K082216 is the FDA 510(k) clearance for TBD ETHICON MESH by Ethicon, Inc.. It is a Class 2 General & Plastic Surgery device (product code FTL) cleared through the Special 510(k) pathway after a 30-day FDA review.

K082216 · Ethicon, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2008
Decision
30d
Days
Class 2
Risk

K082216 is an FDA 510(k) clearance for the TBD ETHICON MESH. Classified as Mesh, Surgical, Polymeric (product code FTL), Class II - Special Controls.

Submitted by Ethicon, Inc. (Somerville, US). The FDA issued a Cleared decision on September 5, 2008 after a review of 30 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.

View all Ethicon, Inc. devices

Submission Details

510(k) Number K082216 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 06, 2008
Decision Date September 05, 2008
Days to Decision 30 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
85d faster than avg
Panel avg: 115d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

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 K082216.
NUVASIVE SURGICAL MESH SYSTEM
K081377 · Nuvasive, Inc. · Jan 2009
ATRIUM PROLITE S MESH
K082748 · Atrium Medical Corp. · Jan 2009
VENTRIO HERNIA PATCH
K081777 · C.R. Bard, Inc. · Sep 2008
PARIETEX COMPOSITE MONO PM MESH
K081126 · Sofradim Production · Aug 2008
GORE INFINIT MESH
K081069 · W.L. Gore & Associates, Inc. · May 2008
PARIETEX PROGRIP MESH
K081050 · Sofradim Production · May 2008