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) Official FDA 510(k) Summary (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.

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
Combination Product No
PCCP Authorized No
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 335
Devices cleared under the same product code (FTL) and FDA review panel - the closest regulatory comparables to K120025.
VENTRIO LIGHT HERNIA PATCH WITH TRM ANTIMICROBIAL COATING
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K113311 · Biocer Entwicklungs GmbH · Jul 2012
PROGRIP LAPARSCOPIC SELF-FIXATING MESH
K120897 · Sofradim Production · Jun 2012
PARIETEX COMPOSITE VENTRAL PATCH
K120506 · Sofradim Production · Jun 2012
C-QUR RPM MESH
K121070 · Atrium Medical Corp. · Apr 2012
HYBRID GRAFT
K111695 · Cook Biotech, Inc. · Apr 2012
K120025 · SURGIMESH XB - SKIRTED
Download PDF FDA Summary Aspide Medical