Cleared Traditional

K003906 - MODIFICATION TO FLUROTEX SURGICAL MESH

K003906 is an FDA 510(k) clearance for MODIFICATION TO FLUROTEX SURGICAL MESH, manufactured by Bridger Biomed, Inc.. The device is a Class 2 General & Plastic Surgery device with product code FTL cleared through the Traditional 510(k) pathway after a 38-day FDA review.

K003906 · Bridger Biomed, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2001
Decision
38d
Days
Class 2
Risk

K003906 is an FDA 510(k) clearance for the MODIFICATION TO FLUROTEX SURGICAL MESH. Classified as Mesh, Surgical, Polymeric (product code FTL), Class II - Special Controls.

Submitted by Bridger Biomed, Inc. (Bozeman, US). The FDA issued a Cleared decision on January 26, 2001 after a review of 38 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 Bridger Biomed, Inc. devices

FDA 510(k) Submission Details - K003906

510(k) Number K003906 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 19, 2000
Decision Date January 26, 2001
Days to Decision 38 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
77d faster than avg
Panel avg: 115d · This submission: 38d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 225
Devices cleared under the same product code (FTL) and FDA review panel - the closest regulatory comparables to K003906.
PROLENE (POLYPROPYLENE) 3D PATCH, NONABSORBABLE SYNTHETIC SURGICAL MESH
K010722 · Ethicon, Inc. · Apr 2001
IVS TUNNELLER
K010035 · United States Surgical, A Division of Tyco Healthc · Apr 2001
GORE-TEX DUALMESH PLUS BIOMATERIAL WITH HOLES
K010228 · W.L. Gore & Associates, Inc. · Feb 2001
SOFRADIM PARIETEX SURGICAL MESHES
K003990 · Sofradim Production · Jan 2001
COMPOSIX KUGEL MESH, MODEL 0010201,0010202,0010203,0010204,0010205
K003323 · Davol, Inc. · Jan 2001
AMS TRIANGLE SILICONE-COATED SLING AND SURGICAL MESH
K002721 · American Medical Systems, Inc. · Nov 2000