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..

337
Total
337
Cleared
119d
Avg days
1979
Since
337 devices
289–312 of 337
Cleared Jul 01, 1997
SIL-TEC NONREINFORCED SHEETING, REINFORCED SHEETING, RADIOPAQUE SHEETING, REINFORCED RADIOPAQUE SHEETING, EXTRA FIRM GRA
K971472
Technical Products, Inc.
General & Plastic Surgery · 69d
Cleared Feb 18, 1997
RAPISEAL PATCH
K964857
Fusion Medical Technologies, Inc.
General & Plastic Surgery · 76d
Cleared Feb 06, 1997
GORE-TEX SOFT TISSUE PATCH PLUS/DUALMESH PLUS BIOMATERIAL/MYCROMESH PLUS BIOMATERIAL/DUALMESH PLUS BIOMATERIAL WITH HOLE
K965038
W.L. Gore & Associates, Inc.
General & Plastic Surgery · 51d
Cleared Jan 27, 1997
S.A.M. FACIAL IMPLANT W/INTRODUCER
K964761
W.L. Gore & Associates, Inc.
General & Plastic Surgery · 61d
Cleared Nov 15, 1996
SURGICAL FABRICS
K963226
Boston Scientific Corp
General & Plastic Surgery · 88d
Cleared Oct 25, 1996
GORE-TEX SOFT TISSUE PATCH,MYCROMESHA BIOMATERIAL,DUALMESH BIOMATERIAL,DUALMESH BIOMATERIAL WITH HOLES
K963619
W.L. Gore & Associates, Inc.
General & Plastic Surgery · 45d
Cleared Oct 11, 1996
KUGEL HERNIA PATCH
K963141
Douglas Bueschel
General & Plastic Surgery · 59d
Cleared Sep 16, 1996
POLYPROPYLENE MESH (VARIOUS SIZES)
K962971
Davis & Geck, Inc.
General & Plastic Surgery · 47d
Cleared Sep 03, 1996
GORE-TEX DUALMESH PLUS BIOMATERIAL WITH HOLES
K962401
W.L. Gore & Associates, Inc.
General & Plastic Surgery · 74d
Cleared Sep 03, 1996
SOFT TISSUE AUGMENTATION TUBE (S.T.A.T.)
K962496
Tissue Technologies, Inc.
General & Plastic Surgery · 69d
Cleared Aug 09, 1996
PROLENE POLYPROPYLENE MESH NONABSORBABLE SYNTHETIC SURGICAL MESH
K962530
Ethicon, Inc.
General & Plastic Surgery · 42d
Cleared May 31, 1996
SURGICAL PATCH, SURGICAL MEMBRANE, SURGICAL MESH
K961440
Fusion Medical Technologies, Inc.
General & Plastic Surgery · 46d
Cleared Apr 01, 1996
SOFT TISSUE AUGMENTATION TUBE
K960481
Tissue Technologies, Inc.
General & Plastic Surgery · 59d
Cleared Mar 15, 1996
PROLEX MESH
K960219
Advanced Surgical Innovations, Inc.
General & Plastic Surgery · 59d
Cleared Feb 14, 1996
GLYCAR STAPLE STRIPS
K954665
Glycar, Inc.
General & Plastic Surgery · 127d
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 Mar 02, 1995
HERNIA MESH INTRODUCTION SYSTEM
K945060
Gerard Medical, Inc.
General & Plastic Surgery · 139d