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
73–96 of 336
Cleared May 30, 2014
ULTRAPRO COMFORT PLUG
K133198
Ethicon, Inc.
General & Plastic Surgery · 225d
Cleared May 07, 2014
PROGRIP SELF-GRIPPING POLYPROPYLENE MESH, PARIETENE FLAT SHEET MESH
K140941
Sofradim Production
General & Plastic Surgery · 23d
Cleared Dec 13, 2013
BARD VENTRALEX HERNIA PATCH
K132441
C.R. Bard, Inc.
General & Plastic Surgery · 129d
Cleared Nov 26, 2013
AIGIS RX N (MEDIUM), AIGIS RX N (LARGE)
K132699
Tyrx, Inc.
General & Plastic Surgery · 89d
Cleared Oct 25, 2013
COVAMESH
K130428
Biomup S.A.
General & Plastic Surgery · 247d
Cleared Oct 23, 2013
DYNAMESH -CICAT
K131530
Feg Textiltechnik Forschungs-Und Entwicklungsgesel
General & Plastic Surgery · 148d
Cleared Aug 22, 2013
SYMBOTEX(TM) COMPOSITE MESH
K131969
Sofradim Production
General & Plastic Surgery · 55d
Cleared Jul 10, 2013
AIGIS RX N MEDIUM
K131007
Tyrx, Inc.
General & Plastic Surgery · 90d
Cleared May 20, 2013
AIGIS RX R PM/ AIGIS RX R ICD
K130943
Tyrx, Inc.
General & Plastic Surgery · 46d
Cleared May 01, 2013
VENTRALIGHT ST MESH WITH ECHO PS POSITIONING SYSTEM
K130968
C.R. Bard, Inc.
General & Plastic Surgery · 23d
Cleared Dec 13, 2012
MEDLINX SURGICAL MESH
K120844
Medlinx Acala Pte, Ltd.
General & Plastic Surgery · 268d
Cleared Dec 11, 2012
PROGRIP LAPAROSCOPIC SELF-FIXATING MESH
K123479
Sofradim Production
General & Plastic Surgery · 28d
Cleared Nov 02, 2012
COMPOSIX L/P MESH WITH ECHO PS POSITIONING SYSTEM VENTRALIGHT ST MESH WITH ECHO PS POSITIONING SYSTEM
K122436
C.R. Bard, Inc.
General & Plastic Surgery · 84d
Cleared Aug 23, 2012
FREEDOM INGUINAL HERNIA IMPLANT
K113552
Insightra Medical
General & Plastic Surgery · 266d
Cleared Jul 20, 2012
VENTRIO LIGHT HERNIA PATCH WITH TRM ANTIMICROBIAL COATING
K113229
C.R. Bard, Inc.
General & Plastic Surgery · 261d
Cleared Jul 17, 2012
TIO2MESH TM
K113311
Biocer Entwicklungs GmbH
General & Plastic Surgery · 251d
Cleared Jun 29, 2012
PROGRIP LAPARSCOPIC SELF-FIXATING MESH
K120897
Sofradim Production
General & Plastic Surgery · 95d
Cleared Jun 26, 2012
SURGIMESH XB - SKIRTED
K120025
Aspide Medical
General & Plastic Surgery · 175d
Cleared Jun 13, 2012
PARIETEX COMPOSITE VENTRAL PATCH
K120506
Sofradim Production
General & Plastic Surgery · 113d
Cleared Apr 26, 2012
C-QUR RPM MESH
K121070
Atrium Medical Corp.
General & Plastic Surgery · 17d
Cleared Apr 02, 2012
HYBRID GRAFT
K111695
Cook Biotech, Inc.
General & Plastic Surgery · 291d
Cleared Jan 25, 2012
TORNIER COLLAGEN COATED BIOFIBER SCAFFOLD
K111337
Tornier, Inc.
General & Plastic Surgery · 258d
Cleared Dec 23, 2011
BIOMERIX COMPOSITE SURGICAL MESH
K112499
Biomerix Corporation
General & Plastic Surgery · 115d
Cleared Dec 23, 2011
BIOMERIX ASSURE
K112567
Biomerix Corporation
General & Plastic Surgery · 112d