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
241–264 of 337
Cleared Oct 17, 2002
BRENNEN MEDICAL SURGICAL MESH, GLUCAMESH/GLUCATEX
K021835
Brennen Medical, Inc.
General & Plastic Surgery · 135d
Cleared Sep 10, 2002
DUALMESH EMERGE & EMERGE PLUS BIOMATERIAL
K022782
W.L. Gore & Associates, Inc.
General & Plastic Surgery · 19d
Cleared Aug 23, 2002
BARD CRURASOFT PATCH, MODELS 0116003 & 0116001
K022350
C.R. Bard, Inc.
General & Plastic Surgery · 35d
Cleared Jul 16, 2002
BARD VENTRALEX HERNIA PATCH, MODELS 0010302, 0010301
K021736
C.R. Bard, Inc.
General & Plastic Surgery · 49d
Cleared Jun 12, 2002
AFB (ABSORBABLE FOAM BUTTRESS)
K014183
J&J Corporate Biomaterials Center
General & Plastic Surgery · 174d
Cleared Dec 03, 2001
MACROPORE SURGIWRAP (TS)
K012025
Macropore Biosurgery, Inc.
General & Plastic Surgery · 158d
Cleared May 24, 2001
BIOSLING - BIOABSORBABLE POLYMER SLING & SURGICAL MESH
K010533
Injectx, Inc.
General & Plastic Surgery · 90d
Cleared Apr 27, 2001
PROLENE (POLYPROPYLENE) 3D PATCH, NONABSORBABLE SYNTHETIC SURGICAL MESH
K010722
Ethicon, Inc.
General & Plastic Surgery · 46d
Cleared Apr 04, 2001
IVS TUNNELLER
K010035
United States Surgical, A Division of Tyco Healthc
General & Plastic Surgery · 90d
Cleared Feb 21, 2001
GORE-TEX DUALMESH PLUS BIOMATERIAL WITH HOLES
K010228
W.L. Gore & Associates, Inc.
General & Plastic Surgery · 28d
Cleared Feb 15, 2001
PARIETEX COMPOSITE (PCO) MESH
K002699
Medical Device Consultants, Inc.
General & Plastic Surgery · 169d
Cleared Jan 26, 2001
MODIFICATION TO FLUROTEX SURGICAL MESH
K003906
Bridger Biomed, Inc.
General & Plastic Surgery · 38d
Cleared Jan 26, 2001
MODIFICATION TO FLUOROTEX II SURGICAL MESH
K003917
Bridger Biomed, Inc.
General & Plastic Surgery · 38d
Cleared Jan 24, 2001
SOFRADIM PARIETEX SURGICAL MESHES
K003990
Sofradim Production
General & Plastic Surgery · 29d
Cleared Jan 22, 2001
COMPOSIX KUGEL MESH, MODEL 0010201,0010202,0010203,0010204,0010205
K003323
Davol, Inc.
General & Plastic Surgery · 90d
Cleared Nov 29, 2000
AMS TRIANGLE SILICONE-COATED SLING AND SURGICAL MESH
K002721
American Medical Systems, Inc.
General & Plastic Surgery · 90d
Cleared Nov 22, 2000
VYPRO MESH, VICRYL PROLENE PARTIALLY ABSORBABLE SYNTHETIC SURGICAL MESH
K002672
Ethicon, Inc.
General & Plastic Surgery · 86d
Cleared Oct 19, 2000
BIOMESH P1 AND BIOMESH PLUG AND PATCH
K002479
Cousin Biotech S.A.R.L
General & Plastic Surgery · 69d
Cleared Oct 11, 2000
COMPOSIX E/X MESH
K002684
C.R. Bard, Inc.
General & Plastic Surgery · 44d
Cleared Aug 26, 2000
FLUOROTEX II SURGICAL MESH
K002351
Bridger Biomed, Inc.
General & Plastic Surgery · 24d
Cleared Jul 24, 2000
SOFTFORM SOFT TISSUE AUGMENTATION TUBE WITH INSERTION TOOL MODIFICATIONS FOR STRANDS AND SUTURE HOLES
K002071
Tissue Technologies, Inc.
General & Plastic Surgery · 17d
Cleared Jul 24, 2000
ATRIUM LITE MESH
K002093
Atrium Medical Corp.
General & Plastic Surgery · 13d
Cleared May 23, 2000
PROLENE SOFT (POLYPROPYLENE), NONABSORBABALE SYNTHETIC SURGICAL MESH
K001122
Ethicon, Inc.
General & Plastic Surgery · 46d
Cleared May 19, 2000
SOFTFORM FACIAL IMPLANT
K000849
Tissue Technologies, Inc.
General & Plastic Surgery · 65d