Cleared Traditional

K073579 - DYNAMESH-PP STANDARD, MODEL PP02NNNN, DYNAMESH-PP LIGHT, MODEL PP01NNNN

K073579 is an FDA 510(k) clearance for DYNAMESH-PP STANDARD, manufactured by Feg Textiltechnik Forschungs-Und Entwicklungsgesel. The device is a Class 2 General & Plastic Surgery device with product code FTL cleared through the Traditional 510(k) pathway after a 242-day FDA review.

K073579 · Feg Textiltechnik Forschungs-Und Entwicklungsgesel · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2008
Decision
242d
Days
Class 2
Risk

K073579 is an FDA 510(k) clearance for the DYNAMESH-PP STANDARD, MODEL PP02NNNN, DYNAMESH-PP LIGHT, MODEL PP01NNNN. Classified as Mesh, Surgical, Polymeric (product code FTL), Class II - Special Controls.

Submitted by Feg Textiltechnik Forschungs-Und Entwicklungsgesel (Stevenage, Hertfordshire, GB). The FDA issued a Cleared decision on August 18, 2008 after a review of 242 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 Feg Textiltechnik Forschungs-Und Entwicklungsgesel devices

FDA 510(k) Submission Details - K073579

510(k) Number K073579 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 20, 2007
Decision Date August 18, 2008
Days to Decision 242 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
127d slower than avg
Panel avg: 115d · This submission: 242d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 204
Devices cleared under the same product code (FTL) and FDA review panel - the closest regulatory comparables to K073579.
BARD 3DMAX MESH
K081010 · Davol Inc., Sub. C. R. Bard, Inc. · Oct 2008
VENTRIO HERNIA PATCH
K081777 · C.R. Bard, Inc. · Sep 2008
TBD ETHICON MESH
K082216 · Ethicon, 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