Cleared Special

K081882 - MODIFICATION TO XYLOS SURGICAL MESH

K081882 is an FDA 510(k) clearance for MODIFICATION TO XYLOS SURGICAL MESH, manufactured by Xylos Corporation. The device is a Class 2 General & Plastic Surgery device with product code FTM cleared through the Special 510(k) pathway after a 9-day FDA review.

K081882 · Xylos Corporation · General & Plastic Surgery device
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Jul 2008
Decision
9d
Days
Class 2
Risk

K081882 is an FDA 510(k) clearance for the MODIFICATION TO XYLOS SURGICAL MESH. Classified as Mesh, Surgical (product code FTM), Class II - Special Controls.

Submitted by Xylos Corporation (Langhorne, US). The FDA issued a Cleared decision on July 11, 2008 after a review of 9 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 Xylos Corporation devices

FDA 510(k) Submission Details - K081882

510(k) Number K081882 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 02, 2008
Decision Date July 11, 2008
Days to Decision 9 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
106d faster than avg
Panel avg: 115d · This submission: 9d
Pathway characteristics
Modification to existing cleared device.

FTM Device Classification - Class 2, Special Controls

Product Code FTM Mesh, Surgical
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 - FTM Mesh, Surgical

All 67
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