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..

336
Total
336
Cleared
118d
Avg days
1979
Since
336 devices
97–120 of 336
Cleared May 30, 2008
GORE INFINIT MESH
K081069
W.L. Gore & Associates, Inc.
General & Plastic Surgery · 45d
Cleared May 28, 2008
PARIETEX PROGRIP MESH
K081050
Sofradim Production
General & Plastic Surgery · 44d
Cleared Apr 16, 2008
C-QUR LITE MESH V-PATCH
K080688
Atrium Medical Corp.
General & Plastic Surgery · 36d
Cleared Apr 16, 2008
C-QUR EDGE MESH V-PATCH
K080691
Atrium Medical Corp.
General & Plastic Surgery · 36d
Cleared Mar 13, 2008
PREVADH MESH
K073287
Sofradim Production
General & Plastic Surgery · 113d
Cleared Aug 31, 2007
IMPLANTECH EPTFE SHEETING, MODEL EPTFE-XXX
K071470
Implantech Associates, Inc.
General & Plastic Surgery · 94d
Cleared Jul 10, 2007
PARIETEX POLYESTER MESH WITH INTRODUCER
K071629
Sofradim Production
General & Plastic Surgery · 26d
Cleared Jun 05, 2007
ULTRAPRO* HERNIA SYSTEM, MODELS UHSL, UHSM, UHSOV
K071249
Ethicon, Inc.
General & Plastic Surgery · 32d
Cleared May 09, 2007
TOPAS SYSTEM
K070993
American Medical Systems, Inc.
General & Plastic Surgery · 30d
Cleared Apr 17, 2007
ULTRAPRO PLUG
K070224
Ethicon, Inc.
General & Plastic Surgery · 83d
Cleared Apr 02, 2007
GORE SEAMGUARD STAPLE LINE REINFORCEMENT MATERIAL FOR CIRCULAR STAPLERS
K070644
W.L. Gore & Associates, Inc.
General & Plastic Surgery · 25d
Cleared Mar 08, 2007
ATRIUM PROLITE ULTRA S MESH
K070192
Atrium Medical Corp.
General & Plastic Surgery · 45d
Cleared Dec 11, 2006
PROCEED VENTRAL PATCH
K061533
Ethicon, Inc.
General & Plastic Surgery · 192d
Cleared Nov 28, 2006
GORE DUALMESH PLUS BIOMATERIAL GORE MYCROMESH PLUS BIOMATERIAL
K063435
W.L. Gore & Associates, Inc.
General & Plastic Surgery · 15d
Cleared Jul 19, 2006
OPTILENE MESH
K061704
Aesculap, Inc.
General & Plastic Surgery · 33d
Cleared Jul 17, 2006
SURGICAL MESH SYSTEM
K053215
Nuvasive, Inc.
General & Plastic Surgery · 242d
Cleared May 25, 2006
PROCEED SURGICAL MESH
K060713
Ethicon, Inc.
General & Plastic Surgery · 69d
Cleared Mar 31, 2006
ATRIUM MEDICAL CORPORATION C-QUR MESH
K050311
Atrium Medical Corp.
General & Plastic Surgery · 416d
Cleared Jan 18, 2006
OPTILENE MESH LP
K053158
Aesculap, Inc.
General & Plastic Surgery · 65d
Cleared Dec 07, 2005
GORE SEAMGUARD STAPLE LINE REINFORCEMENT MATERIAL
K053200
W.L. Gore & Associates, Inc.
General & Plastic Surgery · 21d
Cleared Oct 20, 2005
BARD LARGE PORE SOFT MESH AND SOFT MESH PRESHAPED
K052155
C.R. Bard, Inc.
General & Plastic Surgery · 73d
Cleared Sep 29, 2005
VICRYL * MESH BAG
K051701
Ethicon, Inc.
General & Plastic Surgery · 97d
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