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
169–192 of 336
Cleared Feb 18, 2005
PARIETEX COMPOSITE PCO-OS AND PCO-OB MESHES
K050187
Sofradim Production
General & Plastic Surgery · 22d
Cleared Dec 22, 2004
GORE SEAMGUARD BIOABSORBABLE STAPLE LINE REINFORCEMENT MATERIAL
K043056
W.L. Gore & Associates, Inc.
General & Plastic Surgery · 47d
Cleared Dec 22, 2004
GORE POLYPROPYLENE HERNIA MESH
K043081
W.L. Gore & Associates, Inc.
General & Plastic Surgery · 44d
Cleared Dec 17, 2004
PERMACOL SURGICAL IMPLANT
K043366
Tissue Science Laboratories, Plc
General & Plastic Surgery · 9d
Cleared Nov 08, 2004
VIVOSORB SHEET, MODEL FS01
K042811
Polyganics B.V.,
General & Plastic Surgery · 27d
Cleared Sep 10, 2004
BARD CK PARASTOMAL HERNIA PATCH, MODELS 0118001, 0118002, 0118003, 0118004
K042026
C.R. Bard, Inc.
General & Plastic Surgery · 44d
Cleared Apr 29, 2004
MODIFICATION TO PARIETEX COMPOSITE (PCO) MESH
K040998
Sofradim Production
General & Plastic Surgery · 10d
Cleared Apr 01, 2004
ULTRAPRO MESH
K033337
Ethicon, Inc.
General & Plastic Surgery · 167d
Cleared Mar 01, 2004
BARD SOFT MESH, MODELS 0117001, 0117002, 0117003, 0117004, 0117005, 0117006, 0117007
K033814
C.R. Bard, Inc.
General & Plastic Surgery · 83d
Cleared Jan 15, 2004
UGYTEX MESH
K033376
Sofradim Production
General & Plastic Surgery · 85d
Cleared Nov 28, 2003
GORE SEAMGUARD BIOABSORBABLE STAPLE LINE REINFORCEMENT MATERIAL
K032865
W.L. Gore & Associates, Inc.
General & Plastic Surgery · 77d
Cleared Sep 22, 2003
MACROPORE SURGI-WRAP MAST BIORESORBABLE SHEET
K031955
Macropore Biosurgery, Inc.
General & Plastic Surgery · 89d
Cleared Sep 17, 2003
PROCEED TRILAMINATE SURGICAL MESH
K031925
Ethicon, Inc.
General & Plastic Surgery · 86d
Cleared Aug 15, 2003
GORE-TEX DUALMESH EMERGE PLUS BIOMATERIAL
K032168
W.L. Gore & Associates, Inc.
General & Plastic Surgery · 30d
Cleared Jun 27, 2003
ORTHOMEND
K031188
Tei Biosciences, Inc.
General & Plastic Surgery · 73d
Cleared May 19, 2003
ZIPPERE - BIOABSORBABLE/NON-ABSORBABLE POLYMER SLING & SURGICAL MESH
K030631
Prosurg, Inc.
General & Plastic Surgery · 80d
Cleared Feb 26, 2003
V.A.C. ABDOMINAL DRESSING
K022011
Kinetic Concepts, Inc.
General & Plastic Surgery · 252d
Cleared Feb 20, 2003
SMALL BARD VENTRALEX PATCH
K024008
C.R. Bard, Inc.
General & Plastic Surgery · 78d
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 Dec 03, 2001
MACROPORE SURGIWRAP (TS)
K012025
Macropore Biosurgery, Inc.
General & Plastic Surgery · 158d
Cleared Apr 27, 2001
PROLENE (POLYPROPYLENE) 3D PATCH, NONABSORBABLE SYNTHETIC SURGICAL MESH
K010722
Ethicon, Inc.
General & Plastic Surgery · 46d