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
145–168 of 336
Cleared Feb 14, 2000
GORE-TEX DUALMESH PLUS BIOMATERIAL (1 MM & 2MM)
K000185
W.L. Gore & Associates, Inc.
General & Plastic Surgery · 25d
Cleared Jan 27, 2000
ATRIUM MEDICAL CORPORATION ADVANTA PTFE FACIAL IMPLANT
K992991
Atrium Medical Corp.
General & Plastic Surgery · 142d
Cleared Jul 29, 1999
GORE-TEX DUALMESH BIOMATERIAL
K992189
W.L. Gore & Associates, Inc.
General & Plastic Surgery · 30d
Cleared Jul 12, 1999
PARIETENE POLYPROPYLENE MESH
K991400
Sofradim Production
General & Plastic Surgery · 81d
Cleared Feb 23, 1999
MODIFICATION OF PROLENE (POLYPROPYLENE) HERNIA SYSTEM, NONABSORBABLE SYNTHETIC SURGICAL MESH
K984220
Ethicon, Inc.
General & Plastic Surgery · 90d
Cleared Nov 06, 1998
MESH, SURGICAL, POLYMERIC
K982575
United States Surgical, A Division of Tyco Healthc
General & Plastic Surgery · 105d
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 Sep 10, 1997
PROLENE POLYPROPYLENE MESH HERNIA DEVICE NONABSORBABLE SYNTHETIC SURGICAL MESH
K972412
Ethicon, 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 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 Aug 09, 1996
PROLENE POLYPROPYLENE MESH NONABSORBABLE SYNTHETIC SURGICAL MESH
K962530
Ethicon, Inc.
General & Plastic Surgery · 42d
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 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