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
97–120 of 337
Cleared Dec 23, 2011
BIOMERIX ASSURE
K112567
Biomerix Corporation
General & Plastic Surgery · 112d
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 Jun 14, 2011
HYDROFIX SURGICAL SHEET
K100313
Mimedx Group, Inc.
General & Plastic Surgery · 495d
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 Jun 25, 2010
SURGIMESH XD
K092233
Aspide Medical
General & Plastic Surgery · 337d
Cleared Jun 25, 2010
BIOMESH CA.B.S. 'AIR COMPOSITE, MODELS: CABST1R05T, CABSAIRC7, CABSAIRC09
K093196
Cousin Biotech Sas
General & Plastic Surgery · 259d
Cleared May 13, 2010
BIOMERIX VENTRAL HERNIA REPAIR MESH, MODEL SM3-TAB
K093123
Biomerix Corporation
General & Plastic Surgery · 223d
Cleared May 05, 2010
PARIE TENE PROGRIP MESH
K101197
Sofradim Production
General & Plastic Surgery · 7d