Cleared Special

K120025 - SURGIMESH XB - SKIRTED

K120025 is an FDA 510(k) clearance for SURGIMESH XB - SKIRTED, manufactured by Aspide Medical. The device is a Class 2 General & Plastic Surgery device with product code FTL cleared through the Special 510(k) pathway after a 175-day FDA review.

K120025 · Aspide Medical · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2012
Decision
175d
Days
Class 2
Risk

K120025 is an FDA 510(k) clearance for the SURGIMESH XB - SKIRTED. Classified as Mesh, Surgical, Polymeric (product code FTL), Class II - Special Controls.

Submitted by Aspide Medical (Washington, US). The FDA issued a Cleared decision on June 26, 2012 after a review of 175 days - an extended review 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. 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 Aspide Medical devices

FDA 510(k) Submission Details - K120025

510(k) Number K120025 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 03, 2012
Decision Date June 26, 2012
Days to Decision 175 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
60d slower than avg
Panel avg: 115d · This submission: 175d
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 209
Devices cleared under the same product code (FTL) and FDA review panel - the closest regulatory comparables to K120025.
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