Cleared Traditional

GORE SYNECOR Biomaterial (K152609) - FDA 510(k) Clearance

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K152609 · W.L. Gore & Associates, Inc. · General & Plastic Surgery device
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Dec 2015
Decision
88d
Days
Class 2
Risk

K152609 is an FDA 510(k) clearance for the GORE SYNECOR Biomaterial. Classified as Mesh, Surgical, Polymeric (product code FTL), Class II - Special Controls.

Submitted by W.L. Gore & Associates, Inc. (Elkton, US). The FDA issued a Cleared decision on December 11, 2015 after a review of 88 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all W.L. Gore & Associates, Inc. devices

Submission Details

510(k) Number K152609 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 14, 2015
Decision Date December 11, 2015
Days to Decision 88 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
27d faster than avg
Panel avg: 115d · This submission: 88d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 96
Devices cleared under the same product code (FTL) and FDA review panel - the closest regulatory comparables to K152609.
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K153236 · C.R. Bard, Inc. · May 2016
ECHO 2.0 LAP SYSTEM with VENTRALIGHT ST MESH
K143743 · C.R. Bard, Inc. · Sep 2015
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K142706 · C.R. Bard, Inc. · Mar 2015
ONFLEX Mesh
K142711 · C.R. Bard, Inc. · Mar 2015