Cleared Special

K050187 - PARIETEX COMPOSITE PCO-OS AND PCO-OB MESHES

K050187 is an FDA 510(k) clearance for PARIETEX COMPOSITE PCO-OS AND PCO-OB MESHES, manufactured by Sofradim Production. The device is a Class 2 General & Plastic Surgery device with product code FTL cleared through the Special 510(k) pathway after a 22-day FDA review.

K050187 · Sofradim Production · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2005
Decision
22d
Days
Class 2
Risk

K050187 is an FDA 510(k) clearance for the PARIETEX COMPOSITE PCO-OS AND PCO-OB MESHES. Classified as Mesh, Surgical, Polymeric (product code FTL), Class II - Special Controls.

Submitted by Sofradim Production (Ayer, US). The FDA issued a Cleared decision on February 18, 2005 after a review of 22 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 Sofradim Production devices

FDA 510(k) Submission Details - K050187

510(k) Number K050187 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 27, 2005
Decision Date February 18, 2005
Days to Decision 22 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
93d faster than avg
Panel avg: 115d · This submission: 22d
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 273
Devices cleared under the same product code (FTL) and FDA review panel - the closest regulatory comparables to K050187.
MOTIFMESH SOFT TISSUE PATCH
K050678 · Proxy Biomedical , Ltd. · May 2005
REPOL ANGIMESH, ANGIMESH PRE, FOLDED MESH, REPOL PLUG BASIC, REPOL PLUG CAP, REPOL PLUG FLOWER AND WINGS MESH
K043191 · Angiologica B. M. Srl · May 2005
TISSUE FIXATION SYSTEM
K050418 · Tfs Manufacturing Pty, Ltd. · May 2005
GORE SEAMGUARD BIOABSORBABLE STAPLE LINE REINFORCEMENT MATERIAL
K043056 · W.L. Gore & Associates, Inc. · Dec 2004
GORE POLYPROPYLENE HERNIA MESH
K043081 · W.L. Gore & Associates, Inc. · Dec 2004
PERMACOL SURGICAL IMPLANT
K043366 · Tissue Science Laboratories, Plc · Dec 2004