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
265–288 of 337
Cleared Mar 02, 2000
SEPRAMESH BIOSURGICAL COMPOSITE, MODEL SMBC-XXX
K994328
Genzyme Corp.
General & Plastic Surgery · 71d
Cleared Feb 17, 2000
PERMACOL
K992556
Tissue Science Laboratories, Plc
General & Plastic Surgery · 202d
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 Nov 18, 1999
STAR TEMPORARY WOUND COVER
K983753
Osteogenics, Inc.
General & Plastic Surgery · 398d
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 Jun 22, 1999
BARD SPERMA-TEX PRESHAPED MESH (2.4X5.6), MODEL 0114700
K991637
Davol Inc., Sub. C. R. Bard, Inc.
General & Plastic Surgery · 41d
Cleared Jun 17, 1999
3D ANATOMICAL MESH
K990930
Santerra Medical Technology, Inc.
General & Plastic Surgery · 90d
Cleared Feb 23, 1999
MODIFICATION OF PROLENE (POLYPROPYLENE) HERNIA SYSTEM, NONABSORBABLE SYNTHETIC SURGICAL MESH
K984220
Ethicon, Inc.
General & Plastic Surgery · 90d
Cleared Jan 20, 1999
PARIETEX
K982532
Cogent
General & Plastic Surgery · 184d
Cleared Jan 07, 1999
FLUOROTEX SURGICAL MESH
K984197
Bridger Biomed, Inc.
General & Plastic Surgery · 45d
Cleared Nov 06, 1998
MESH, SURGICAL, POLYMERIC
K982575
United States Surgical, A Division of Tyco Healthc
General & Plastic Surgery · 105d
Cleared Sep 22, 1998
SOFT TISSUE AUGMENTATION YUBE WITH INSERTION TOOL
K982475
Tissue Technologies, Inc.
General & Plastic Surgery · 68d
Cleared Aug 05, 1998
SHELHIGH NO-REACT PNEUMOPLEDGETS
K981756
Shelhigh, Inc.
General & Plastic Surgery · 79d
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