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 C.R. Bard, Inc., Sofradim Production and Ethicon, Inc..

336
Total
336
Cleared
118d
Avg days
1979
Since
336 devices
49–72 of 336
Cleared Mar 20, 2015
ONFLEX Mesh
K142711
C.R. Bard, Inc.
General & Plastic Surgery · 179d
Cleared Dec 13, 2013
BARD VENTRALEX HERNIA PATCH
K132441
C.R. Bard, Inc.
General & Plastic Surgery · 129d
Cleared May 01, 2013
VENTRALIGHT ST MESH WITH ECHO PS POSITIONING SYSTEM
K130968
C.R. Bard, Inc.
General & Plastic Surgery · 23d
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 Jul 20, 2012
VENTRIO LIGHT HERNIA PATCH WITH TRM ANTIMICROBIAL COATING
K113229
C.R. Bard, Inc.
General & Plastic Surgery · 261d
Cleared Nov 22, 2011
RENASYS AB ABOMINAL DRESSING KIT
K112784
Smith & Nephew, Inc.
General & Plastic Surgery · 57d
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 Dec 16, 2010
COMPOSIX L/P MESH WITH ECHO PS POSITIONING SYSTEM
K102766
C.R. Bard, Inc.
General & Plastic Surgery · 83d
Cleared Sep 17, 2010
RENASYS F/-AB ABDOMINAL WOUND DRESSING KIT
K100787
Smith & Nephew, Inc.
General & Plastic Surgery · 182d
Cleared Apr 21, 2010
VENTRIO HERNIA PATCH
K100229
C.R. Bard, Inc.
General & Plastic Surgery · 85d
Cleared Aug 03, 2009
BARD 3DMAX LIGHT MESH, MODELS: 0117310, 0117311, 0117312, 0117320, 0117321, 011732
K091659
C.R. Bard, Inc.
General & Plastic Surgery · 55d
Cleared Sep 29, 2008
VENTRIO HERNIA PATCH
K081777
C.R. Bard, Inc.
General & Plastic Surgery · 98d
Cleared Oct 20, 2005
BARD LARGE PORE SOFT MESH AND SOFT MESH PRESHAPED
K052155
C.R. Bard, Inc.
General & Plastic Surgery · 73d
Cleared Sep 10, 2004
BARD CK PARASTOMAL HERNIA PATCH, MODELS 0118001, 0118002, 0118003, 0118004
K042026
C.R. Bard, Inc.
General & Plastic Surgery · 44d
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 Feb 20, 2003
SMALL BARD VENTRALEX PATCH
K024008
C.R. Bard, Inc.
General & Plastic Surgery · 78d
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 Apr 04, 2001
IVS TUNNELLER
K010035
United States Surgical, A Division of Tyco Healthc
General & Plastic Surgery · 90d
Cleared Oct 11, 2000
COMPOSIX E/X MESH
K002684
C.R. Bard, Inc.
General & Plastic Surgery · 44d
Cleared Nov 06, 1998
MESH, SURGICAL, POLYMERIC
K982575
United States Surgical, A Division of Tyco Healthc
General & Plastic Surgery · 105d
Cleared Nov 15, 1996
SURGICAL FABRICS
K963226
Boston Scientific Corp
General & Plastic Surgery · 88d