Cleared Traditional

K173796 - Parietex Surgical Mesh (modified into Parietex Hydrophilic 2D, 3D, Anatomical Mesh), Parietex Composite Mesh (PCO and PCO-OS references), Parietex Optimized Composite Mesh (PCO-X, PCO-FX and PCO-OSX references)

K173796 is an FDA 510(k) clearance for Parietex Surgical Mesh (modified into P..., manufactured by Sofradim Production. The device is a Class 2 General & Plastic Surgery device with product code FTL cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K173796 · Sofradim Production · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2018
Decision
85d
Days
Class 2
Risk

K173796 is an FDA 510(k) clearance for the Parietex Surgical Mesh (modified into Parietex Hydrophilic 2D, 3D, Anatomical.... Classified as Mesh, Surgical, Polymeric (product code FTL), Class II - Special Controls.

Submitted by Sofradim Production (Trévoux, FR). The FDA issued a Cleared decision on March 9, 2018 after a review of 85 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Sofradim Production devices

FDA 510(k) Submission Details - K173796

510(k) Number K173796 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 14, 2017
Decision Date March 09, 2018
Days to Decision 85 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
30d faster than avg
Panel avg: 115d · This submission: 85d
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 Consultant

Coviden
Angela Van Arsdale

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - FTL Mesh, Surgical, Polymeric

All 272
Devices cleared under the same product code (FTL) and FDA review panel - the closest regulatory comparables to K173796.
TYRX Neuro Absorbable Antibacterial Envelope (medium)
K180122 · Medtronic, Inc. · Jun 2018
VitaMESH Macroporous PP Surgical Mesh
K172636 · Proxy Biomedical , Ltd. · Apr 2018
TYRX Absorbable Antibacterial Envelope (medium), TYRX Absorbable Antibacterial Envelope (large)
K180030 · Medtronic, Inc. · Apr 2018
Duatene bilayer mesh
K172395 · Sofradim Production · Feb 2018
PROLENE Soft Polypropylene Mesh
K172089 · Ethicon, Inc. · Oct 2017
Reperen Surgical Mesh
K170134 · Iconlab, Inc. · Aug 2017