Cleared Special

K220586 - Symbotex Composite Mesh, ProGrip Self-Gripping Polyester Mesh, Parietex Hydrophilic 2D 3D Anatomical Mesh, Versatex Monofilament Mesh (FDA 510(k) Clearance)

Class II General & Plastic Surgery device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K220586 · Sofradim Production · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2022
Decision
113d
Days
Class 2
Risk

K220586 is an FDA 510(k) clearance for the Symbotex Composite Mesh, ProGrip Self-Gripping Polyester Mesh, Parietex Hydro.... 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 June 22, 2022 after a review of 113 days - within the typical 510(k) review window.

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. Standard predicate reliance. 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

Submission Details

510(k) Number K220586 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 01, 2022
Decision Date June 22, 2022
Days to Decision 113 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
1d faster than avg
Panel avg: 114d · This submission: 113d
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 Consultant

Covidien, LLC
Wing Ng

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 334
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