Cleared Special

K082216 - TBD ETHICON MESH

K082216 is an FDA 510(k) clearance for TBD ETHICON MESH, manufactured by Ethicon, Inc.. The device is a Class 2 General & Plastic Surgery device with 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) Official FDA 510(k) Summary (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.

FDA 510(k) Submission Details - K082216

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.

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 K082216.
BARD 3DMAX MESH
K081010 · Davol Inc., Sub. C. R. Bard, Inc. · Oct 2008
VENTRIO HERNIA PATCH
K081777 · C.R. Bard, Inc. · Sep 2008
SUPRAMESH EXTRA
K080216 · S. Jackson, Inc. · Sep 2008
SURGIMESH XB
K072974 · Aspide Medical · Aug 2008
DYNAMESH-PP STANDARD, MODEL PP02NNNN, DYNAMESH-PP LIGHT, MODEL PP01NNNN
K073579 · Feg Textiltechnik Forschungs-Und Entwicklungsgesel · Aug 2008
PARIETEX COMPOSITE MONO PM MESH
K081126 · Sofradim Production · Aug 2008
K082216 · TBD ETHICON MESH
Download PDF FDA Summary Ethicon, Inc.