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
217–240 of 336
Cleared May 20, 1998
SIS HERNIA REPAIR DEVICE
K974540
Sentron Medical, Inc.
General & Plastic Surgery · 168d
Cleared May 11, 1998
HERNIAMESH SURGICAL MESHES
K973955
Herniamesh
General & Plastic Surgery · 207d
Cleared Apr 30, 1998
MENTOR SUSPEND SLING
K980483
Mentor Corp.
General & Plastic Surgery · 80d
Cleared Apr 15, 1998
SOFT TISSUE PATCH PLUS, DUALMESH PLUS, MYCROMESH PLUS, DUALMESH PLUS WITH HOLES
K981051
W.L. Gore & Associates, Inc.
General & Plastic Surgery · 28d
Cleared Nov 24, 1997
SOFTFORM FACIAL IMPLANT
K973462
Tissue Technologies, Inc.
General & Plastic Surgery · 73d
Cleared Nov 04, 1997
VENTRAL WALL DEFECT REDUCTION SILO
K973082
Specialty Surgical Products, Inc.
General & Plastic Surgery · 78d
Cleared Sep 10, 1997
PROLENE POLYPROPYLENE MESH HERNIA DEVICE NONABSORBABLE SYNTHETIC SURGICAL MESH
K972412
Ethicon, Inc.
General & Plastic Surgery · 76d
Cleared Aug 06, 1997
BARD COMPOSITE PROSTHESIS
K971745
Davol Inc., Sub. C. R. Bard, Inc.
General & Plastic Surgery · 86d
Cleared Aug 01, 1997
GRAFT PATCH
K970561
Organogenesis, Inc.
General & Plastic Surgery · 169d
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