Cleared Special

K053202 - GORE SEAMGUARD BIOABSORBABLE STAPLE LINE REINFORCEMENT MATERIAL

K053202 is an FDA 510(k) clearance for GORE SEAMGUARD BIOABSORBABLE STAPLE LIN..., manufactured by W.L. Gore & Associates. The device is a Class 2 General & Plastic Surgery device with product code FTL cleared through the Special 510(k) pathway after a 21-day FDA review.

K053202 · W.L. Gore & Associates · General & Plastic Surgery device
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Dec 2005
Decision
21d
Days
Class 2
Risk

K053202 is an FDA 510(k) clearance for the GORE SEAMGUARD BIOABSORBABLE STAPLE LINE REINFORCEMENT MATERIAL. Classified as Mesh, Surgical, Polymeric (product code FTL), Class II - Special Controls.

Submitted by W.L. Gore & Associates (Flagstaff, US). The FDA issued a Cleared decision on December 7, 2005 after a review of 21 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 W.L. Gore & Associates devices

FDA 510(k) Submission Details - K053202

510(k) Number K053202 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 16, 2005
Decision Date December 07, 2005
Days to Decision 21 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
94d faster than avg
Panel avg: 115d · This submission: 21d
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 212
Devices cleared under the same product code (FTL) and FDA review panel - the closest regulatory comparables to K053202.
CALDERA MESH
K060004 · Caldera Medical, Inc. · Feb 2006
OPTILENE MESH LP
K053158 · Aesculap, Inc. · Jan 2006
GORE SEAMGUARD STAPLE LINE REINFORCEMENT MATERIAL
K053200 · W.L. Gore & Associates, Inc. · Dec 2005
BARD LARGE PORE SOFT MESH AND SOFT MESH PRESHAPED
K052155 · C.R. Bard, Inc. · Oct 2005
VICRYL * MESH BAG
K051701 · Ethicon, Inc. · Sep 2005
ORTHOMEND
K051766 · Tei Biosciences, Inc. · Aug 2005