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
121–144 of 336
Cleared Jun 04, 2009
C-QUR V -PATCH MESH
K090909
Atrium Medical Corp.
General & Plastic Surgery · 64d
Cleared Jun 02, 2009
PFR SLING SYSTEM, PART OF THE AMS PELVIC FLOOR REPAIR SYSTEM
K090934
American Medical Systems, Inc.
General & Plastic Surgery · 61d
Cleared May 14, 2009
ABTHERA OPEN ABDOMEN DRESSING, MODEL: M8275026
K090489
Kci USA, Inc.
General & Plastic Surgery · 78d
Cleared May 06, 2009
PARIETEX MONOFILAMENT POLYESTER MESH
K090858
Sofradim Production
General & Plastic Surgery · 37d
Cleared Mar 27, 2009
GORE BIO-A FISTULA PLUG
K083266
W.L. Gore & Associates, Inc.
General & Plastic Surgery · 142d
Cleared Jan 15, 2009
NUVASIVE SURGICAL MESH SYSTEM
K081377
Nuvasive, Inc.
General & Plastic Surgery · 244d
Cleared Jan 14, 2009
ATRIUM PROLITE S MESH
K082748
Atrium Medical Corp.
General & Plastic Surgery · 117d
Cleared Oct 07, 2008
BARD 3DMAX MESH
K081010
Davol Inc., Sub. C. R. Bard, Inc.
General & Plastic Surgery · 181d
Cleared Sep 29, 2008
VENTRIO HERNIA PATCH
K081777
C.R. Bard, Inc.
General & Plastic Surgery · 98d
Cleared Sep 15, 2008
SUPRAMESH EXTRA
K080216
S. Jackson, Inc.
General & Plastic Surgery · 230d
Cleared Sep 05, 2008
TBD ETHICON MESH
K082216
Ethicon, Inc.
General & Plastic Surgery · 30d
Cleared Aug 13, 2008
PARIETEX COMPOSITE MONO PM MESH
K081126
Sofradim Production
General & Plastic Surgery · 114d
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 Dec 31, 2007
KENSEY NASH MACROPORE SHIELD
K071695
Kensey Nash Corp.
General & Plastic Surgery · 194d
Cleared Nov 29, 2007
TEPHAFLEX SURGICAL FILM
K072520
Tepha, Inc.
General & Plastic Surgery · 83d
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 Jul 02, 2007
MINISLING ADJUSTABLE POLYMER SLING & SURGICAL MESH WITH SELF-ANCHORING SYSTEM
K070846
Prosurg, Inc.
General & Plastic Surgery · 96d
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