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
97–120 of 336
Cleared Nov 22, 2011
RENASYS AB ABOMINAL DRESSING KIT
K112784
Smith & Nephew, Inc.
General & Plastic Surgery · 57d
Cleared Aug 11, 2011
PAIRETEX OPTIMIZED COMPOSITE MESH (PCO-FX REFRENCES)
K110663
Sofradim Production
General & Plastic Surgery · 156d
Cleared May 13, 2011
VITAMESH (TM) BLUE LIGHTWEIGHT MACROPOROUS PP SURGICAL MESH
K111121
Proxy Biomedical , Ltd.
General & Plastic Surgery · 22d
Cleared May 10, 2011
TORNIER BIOFIBER SCAFFOLD
K102788
Tornier, Inc.
General & Plastic Surgery · 228d
Cleared Apr 19, 2011
PARIETEX OPTIMIZED COMPOSTIE MESH
K110815
Sofradim Production
General & Plastic Surgery · 26d
Cleared Apr 19, 2011
PARIETEX OPTIMIZED COMPOSITE MESH (PCO-OSX REFERENCES)
K110816
Sofradim Production
General & Plastic Surgery · 26d
Cleared Apr 01, 2011
VENTRALIGHT (TM) ST MESH WITH ECHO PS (TM) POSITIONING SYSTEM
K110820
C.R. Bard, Inc.
General & Plastic Surgery · 9d
Cleared Mar 23, 2011
VENTRIO ST HERNIA PATCH
K101920
C.R. Bard, Inc.
General & Plastic Surgery · 257d
Cleared Mar 23, 2011
VENTRALEX ST HERNIA PATCH
K101928
C.R. Bard, Inc.
General & Plastic Surgery · 257d
Cleared Mar 04, 2011
PARIETEX PROGRIP
K103682
Sofradim Production
General & Plastic Surgery · 77d
Cleared Feb 22, 2011
ALACER SURGICAL SCAFFOLD
K103445
Alacer Biomedical, Inc.
General & Plastic Surgery · 90d
Cleared Feb 15, 2011
ATRIUM CENTRILFX MESH
K110110
Atrium Medical Corporation
General & Plastic Surgery · 32d
Cleared Dec 22, 2010
RESTORELLE POLYPROPYLENE MESH
K103568
Coloplast A/S
General & Plastic Surgery · 16d
Cleared Dec 16, 2010
COMPOSIX L/P MESH WITH ECHO PS POSITIONING SYSTEM
K102766
C.R. Bard, Inc.
General & Plastic Surgery · 83d
Cleared Nov 05, 2010
PARIETEX PLUG AND PATCH
K101519
Sofradim Production
General & Plastic Surgery · 156d
Cleared Sep 17, 2010
RENASYS F/-AB ABDOMINAL WOUND DRESSING KIT
K100787
Smith & Nephew, Inc.
General & Plastic Surgery · 182d
Cleared Aug 16, 2010
ASCEND BLUE AC MESH
K101462
Caldera Medical, Inc.
General & Plastic Surgery · 82d
Cleared Jul 15, 2010
VENTRALIGHT ST MESH
K101851
Davol Inc., Sub. C. R. Bard, Inc.
General & Plastic Surgery · 14d
Cleared May 05, 2010
PARIE TENE PROGRIP MESH
K101197
Sofradim Production
General & Plastic Surgery · 7d
Cleared Apr 22, 2010
TORNIER SURGICAL MESH
K093799
Tornier, Inc.
General & Plastic Surgery · 133d
Cleared Apr 21, 2010
VENTRIO HERNIA PATCH
K100229
C.R. Bard, Inc.
General & Plastic Surgery · 85d
Cleared Jan 26, 2010
ATRIUM C-QUR OVT MESH
K100076
Atrium Medical Corp.
General & Plastic Surgery · 14d
Cleared Dec 08, 2009
BARD PERFIX LIGHT PLUG, MODELS 0117050, 0117060, 0117070, 0117080, 0117150, 0117160
K092032
Davol Inc., Sub. C. R. Bard, Inc.
General & Plastic Surgery · 155d
Cleared Aug 03, 2009
BARD 3DMAX LIGHT MESH, MODELS: 0117310, 0117311, 0117312, 0117320, 0117321, 011732
K091659
C.R. Bard, Inc.
General & Plastic Surgery · 55d