Cleared Special

K253125 - Parietene™ Flat Sheet Mesh (FDA 510(k) Clearance)

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

K253125 · Medtronic - Sofradim Production · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2025
Decision
29d
Days
Class 2
Risk

K253125 is an FDA 510(k) clearance for the Parietene™ Flat Sheet Mesh. Classified as Mesh, Surgical, Polymeric (product code FTL), Class II - Special Controls.

Submitted by Medtronic - Sofradim Production (Trévoux, FR). The FDA issued a Cleared decision on October 24, 2025 after a review of 29 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 Medtronic - Sofradim Production devices

Submission Details

510(k) Number K253125 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 25, 2025
Decision Date October 24, 2025
Days to Decision 29 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
85d faster than avg
Panel avg: 114d · This submission: 29d
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 Peers - FTL Mesh, Surgical, Polymeric

All 334
Devices cleared under the same product code (FTL) and FDA review panel - the closest regulatory comparables to K253125.
Onflex™ Mesh
K251955 · Davol Inc., Subsidiary of C. R. Bard, Inc. · Jul 2025
Bard® Mesh
K251557 · Davol, Inc. · Jun 2025
Parietene™ Macroporous Mesh (PPM5050 )
K250869 · Sofradim Production · Apr 2025
Bard Soft Mesh
K250098 · Davol, Inc. · Apr 2025
ProGrip™ Self-Gripping Polypropylene Mesh
K243315 · Sofradim Production · Jan 2025
3DMax Light Mesh
K241250 · Davol Inc., Subsidiary of C. R. Bard, Inc. · Jun 2024