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

337
Total
337
Cleared
119d
Avg days
1979
Since
337 devices
313–336 of 337
Cleared Feb 13, 1995
GORE-TEX(R) CURVED SURGICALMEMBRANE
K945899
W.L. Gore & Associates, Inc.
General & Plastic Surgery · 73d
Cleared Dec 14, 1994
GLYCAR TISSUE REPAIR PATCH
K942911
Glycar, Inc.
General & Plastic Surgery · 176d
Cleared Dec 08, 1994
TRELEX NATURAL(R) MESH
K945377
Meadox Medicals, Div. Boston Scientific Corp.
General & Plastic Surgery · 45d
Cleared Nov 09, 1994
ACM PTFE SURGICAL MESH
K944413
American Custom Medical, Inc.
General & Plastic Surgery · 62d
Cleared Sep 29, 1994
GORE-TEX SOFT TISSUE PATCH PLUS
K922452
W.L. Gore & Associates, Inc.
General & Plastic Surgery · 856d
Cleared Aug 23, 1994
FLARED PATCH
K941299
Flared Patch, Inc.
General & Plastic Surgery · 159d
Cleared Jul 08, 1994
PERI-STRIPS PLANAR CONFIGURATION STAPLE LINE REINFORCEMENT
K942583
Bio-Vascular, Inc.
General & Plastic Surgery · 37d
Cleared Jun 30, 1994
BIOSIL MEDICAL GRADE SILICONE SHEETING FOR OBSTETRICAL & GYNOCOLOGY APPLICATIONS
K933827
Bioplexus Corp.
General & Plastic Surgery · 329d
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
Cleared Jun 27, 1984
VENTRAL WALL DEFECT REDUCT SILO
K840172
American Heyer Schulte
General & Plastic Surgery · 162d
Cleared Jan 10, 1984
STERILIZATION OF GORE-TEX SOFT TISSU
K833764
W.L. Gore & Associates, Inc.
General & Plastic Surgery · 76d
Cleared Mar 26, 1982
GORE-TEX TISSUE REINFORCEMENT PATCH
K820193
W.L. Gore & Associates, Inc.
General & Plastic Surgery · 60d
Cleared Mar 13, 1981
VICRYL
K810428
Ethicon, Inc.
General & Plastic Surgery · 23d