FTL · Class II · 21 CFR 878.3300

FDA Product Code FTL: Mesh, Surgical, Polymeric

Surgical mesh has transformed the repair of abdominal wall defects. FDA product code FTL covers polymeric surgical mesh used for tissue reinforcement and repair.

These woven or knitted synthetic materials — typically polypropylene or polyester — provide structural support to weakened or deficient tissue in hernia repair, pelvic floor reconstruction, and other procedures where native tissue alone is insufficient for durable closure.

FTL devices are Class II medical devices, regulated under 21 CFR 878.3300 and reviewed by the FDA General & Plastic Surgery panel.

Leading manufacturers include W.L. Gore & Associates, Inc., Sofradim Production and C.R. Bard, Inc..

336
Total
336
Cleared
118d
Avg days
1979
Since
336 devices
241–264 of 336
Cleared Jan 24, 1996
GORE-TEX DUALMESH BIOMATERIAL WITH HOLES
K955494
W.L. Gore & Associates, Inc.
General & Plastic Surgery · 54d
Cleared Nov 14, 1995
GORE-TEX SAM FACIAL IMPLANT WITH INTRODUCER
K952898
W.L. Gore & Associates, Inc.
General & Plastic Surgery · 144d
Cleared Oct 07, 1995
GORE-TEX MYCROMESH BIOMATERIAL
K951675
W.L. Gore & Associates, Inc.
General & Plastic Surgery · 179d
Cleared Oct 07, 1995
GORE-TEX DUALMESH BIOMATERIAL
K951676
W.L. Gore & Associates, Inc.
General & Plastic Surgery · 179d
Cleared Oct 07, 1995
GORE-TEX SOFT TISSUE PATCH
K951700
W.L. Gore & Associates, Inc.
General & Plastic Surgery · 178d
Cleared Sep 26, 1995
BARD VISILEX MESH 3 X 6
K953577
Davol Inc., Sub. C. R. Bard, Inc.
General & Plastic Surgery · 57d
Cleared Apr 24, 1995
GORE-TEX DUALMESH PLUS BIOMATERIAL
K946106
W.L. Gore & Associates, Inc.
General & Plastic Surgery · 131d
Cleared Apr 24, 1995
GORE-TEX MYCROMESH PLUS BIOMATERIAL
K946107
W.L. Gore & Associates, Inc.
General & Plastic Surgery · 131d
Cleared Feb 13, 1995
GORE-TEX(R) CURVED SURGICALMEMBRANE
K945899
W.L. Gore & Associates, Inc.
General & Plastic Surgery · 73d
Cleared Dec 08, 1994
TRELEX NATURAL(R) MESH
K945377
Meadox Medicals, Div. Boston Scientific Corp.
General & Plastic Surgery · 45d
Cleared Sep 29, 1994
GORE-TEX SOFT TISSUE PATCH PLUS
K922452
W.L. Gore & Associates, Inc.
General & Plastic Surgery · 856d
Cleared Jul 08, 1994
PERI-STRIPS PLANAR CONFIGURATION STAPLE LINE REINFORCEMENT
K942583
Bio-Vascular, Inc.
General & Plastic Surgery · 37d
Cleared Jan 28, 1994
GORE-TEX SOFT TISSUE PATCH,SURGICAL MEMBRANE,MESH
K930822
W.L. Gore & Associates, Inc.
General & Plastic Surgery · 345d
Cleared Jan 10, 1994
GIANTURCO-HELFRICH HERNIS MESH
K931936
Cook, Inc.
General & Plastic Surgery · 266d
Cleared Dec 16, 1993
ATRIUM POLYPROPYLENE MESH
K930669
Atrium Medical Corp.
General & Plastic Surgery · 308d
Cleared Nov 29, 1993
GORE-TEK(R) SOFT TISSUE PATCH
K926478
W.L. Gore & Associates, Inc.
General & Plastic Surgery · 335d
Cleared Oct 29, 1993
GORE-TEX MICRO MESH
K931150
W.L. Gore & Associates, Inc.
General & Plastic Surgery · 234d
Cleared Sep 09, 1993
GORE-TEX(TM) DUAL MESH
K926565
W.L. Gore & Associates, Inc.
General & Plastic Surgery · 252d
Cleared Feb 12, 1993
AUTO SUTURE SURGICAL MESH DEPLOYER
K925148
United States Surgical, A Division of Tyco Healthc
General & Plastic Surgery · 122d
Cleared Nov 23, 1992
TRELEX MESH
K924749
Meadox Medicals, Div. Boston Scientific Corp.
General & Plastic Surgery · 62d
Cleared Aug 24, 1992
BARD MARLEX MESH DART
K922916
C.R. Bard, Inc.
General & Plastic Surgery · 68d
Cleared May 29, 1992
COATED SURGIPRO(TM) POLYPROPYLENE SURGICAL MESH
K915526
United States Surgical, A Division of Tyco Healthc
General & Plastic Surgery · 171d
Cleared Dec 04, 1991
GORE-TEX(R) SOFT TISSUE PATCH, PROCESS CHANGE
K914449
W.L. Gore & Associates, Inc.
General & Plastic Surgery · 61d
Cleared Dec 31, 1990
NONABSORBABLE POLYPROPYLENE SURGICAL MESH
K905655
United States Surgical, A Division of Tyco Healthc
General & Plastic Surgery · 13d