Cleared Special

K143386 - Progrip Laparoscopic Self-Fixating Mesh

K143386 is the FDA 510(k) clearance for Progrip Laparoscopic Self-Fixating Mesh by Sofradim Production. It is a Class 2 General & Plastic Surgery device (product code FTL) cleared through the Special 510(k) pathway after a 107-day FDA review.

K143386 · Sofradim Production · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
Mar 2015
Decision
107d
Days
Class 2
Risk

K143386 is an FDA 510(k) clearance for the Progrip Laparoscopic Self-Fixating Mesh. 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 13, 2015 after a review of 107 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 K143386 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 26, 2014
Decision Date March 13, 2015
Days to Decision 107 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
8d faster than avg
Panel avg: 115d · This submission: 107d
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

Surgical Devices, A Global Business Unit of Covidien
Mary Mellows

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

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