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
145–168 of 337
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 18, 2008
SURGIMESH XB
K072974
Aspide Medical
General & Plastic Surgery · 301d
Cleared Aug 18, 2008
DYNAMESH-PP STANDARD, MODEL PP02NNNN, DYNAMESH-PP LIGHT, MODEL PP01NNNN
K073579
Feg Textiltechnik Forschungs-Und Entwicklungsgesel
General & Plastic Surgery · 242d
Cleared Aug 13, 2008
PARIETEX COMPOSITE MONO PM MESH
K081126
Sofradim Production
General & Plastic Surgery · 114d
Cleared Jul 24, 2008
SURGICRAFT SURGICAL MESH SYSTEM
K072370
Surgicraft , Ltd.
General & Plastic Surgery · 336d
Cleared Jun 26, 2008
CABS'AIR
K072962
Cousin Biotech Sas
General & Plastic Surgery · 251d
Cleared Jun 19, 2008
RELIMESH
K081327
Herniamesh S.R.L.
General & Plastic Surgery · 38d
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 21, 2008
MODIFICATION TO ENDOFAST RELIANT SYSTEM
K080836
Endogun Medical Systems
General & Plastic Surgery · 27d
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 Apr 03, 2008
LTM-T SURGICAL MESH
K080353
Lifecell Corp.
General & Plastic Surgery · 52d
Cleared Mar 13, 2008
PREVADH MESH
K073287
Sofradim Production
General & Plastic Surgery · 113d
Cleared Mar 13, 2008
MODIFICATION TO REBOUND HRD
K080393
Minnesota Medical Development, Inc.
General & Plastic Surgery · 29d
Cleared Mar 05, 2008
IVS TUNNELLER DEVICES
K073164
Covidien UK Manufacturing, Ltd.
General & Plastic Surgery · 117d
Cleared Feb 25, 2008
BIOMERIX SURGICAL MESH, MODEL: RCR-01
K070961
Biomerix Corporation
General & Plastic Surgery · 326d
Cleared Jan 16, 2008
PIVIT CRM (TYRX ANTIMICROBIAL PACEMAKER POUCH), MODEL CMRM-0601
K063091
Tyrx Pharma, Inc.
General & Plastic Surgery · 463d
Cleared Jan 16, 2008
ORTHO-WRAP BIORESORBABLE SHEET
K072190
Mast Biosurgery
General & Plastic Surgery · 163d
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