Cleared Traditional

K984197 - FLUOROTEX SURGICAL MESH

K984197 is an FDA 510(k) clearance for FLUOROTEX 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 45-day FDA review.

K984197 · Bridger Biomed, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1999
Decision
45d
Days
Class 2
Risk

K984197 is an FDA 510(k) clearance for the FLUOROTEX 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 7, 1999 after a review of 45 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 - K984197

510(k) Number K984197 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 23, 1998
Decision Date January 07, 1999
Days to Decision 45 days
Submission Type Traditional
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
70d faster than avg
Panel avg: 115d · This submission: 45d
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 224
Devices cleared under the same product code (FTL) and FDA review panel - the closest regulatory comparables to K984197.
3D ANATOMICAL MESH
K990930 · Santerra Medical Technology, Inc. · Jun 1999
MODIFICATION OF PROLENE (POLYPROPYLENE) HERNIA SYSTEM, NONABSORBABLE SYNTHETIC SURGICAL MESH
K984220 · Ethicon, Inc. · Feb 1999
PARIETEX
K982532 · Cogent · Jan 1999
MESH, SURGICAL, POLYMERIC
K982575 · United States Surgical, A Division of Tyco Healthc · Nov 1998
SOFT TISSUE AUGMENTATION YUBE WITH INSERTION TOOL
K982475 · Tissue Technologies, Inc. · Sep 1998
SHELHIGH NO-REACT PNEUMOPLEDGETS
K981756 · Shelhigh, Inc. · Aug 1998