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..

337
Total
337
Cleared
119d
Avg days
1979
Since
337 devices
169–192 of 337
Cleared Sep 18, 2007
SPORTMESH OR ARTELON TISSUE REINFORCEMENT
K071887
Artimplant AB
General & Plastic Surgery · 71d
Cleared Aug 31, 2007
IMPLANTECH EPTFE SHEETING, MODEL EPTFE-XXX
K071470
Implantech Associates, Inc.
General & Plastic Surgery · 94d
Cleared Aug 22, 2007
4DDOME
K070918
Cousin Biotech
General & Plastic Surgery · 142d
Cleared Aug 16, 2007
REBOUND HRD
K063671
Minnesota Medical Development, Inc.
General & Plastic Surgery · 248d
Cleared Aug 01, 2007
PELVIMESH / HERMESH 7
K070625
Marketing Solutions, Inc.
General & Plastic Surgery · 148d
Cleared Jul 17, 2007
XTAC
K061934
Osteogenics, Inc.
General & Plastic Surgery · 375d
Cleared Jul 10, 2007
FACIAL RECONSTRUCTIVE MESH (FRM)
K063154
Evera Medical, Inc.
General & Plastic Surgery · 267d
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
Cleared Apr 27, 2007
UNIVERSAL SURGICAL MESH, MODEL 100
K070018
Generic Medical Device, Inc.
General & Plastic Surgery · 114d
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 Mar 07, 2007
SURGI-WRAP MAST TENDON SHEET
K063648
Mast Biosurgery USA, Inc.
General & Plastic Surgery · 90d
Cleared Feb 01, 2007
SURGIMESH WN
K061445
Aspide Medical
General & Plastic Surgery · 253d
Cleared Jan 17, 2007
SEPRAMESH, MODEL 5959-1214
K063739
Genzyme Corporation
General & Plastic Surgery · 30d
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 Oct 23, 2006
BARD COMPOSITE L/P MESH
K061754
Davol Inc., Sub. C. R. Bard, Inc.
General & Plastic Surgery · 124d
Cleared Oct 13, 2006
SIS HERNIA REPAIR DEVICE, SURGISIS GOLD HERNIA REPAIR GRAFT
K062697
Cook Biotech, Inc.
General & Plastic Surgery · 32d
Cleared Sep 21, 2006
SURGI-WRAP MAST BIORESORBABLE SHEET
K061473
Mast Biosurgery USA, Inc.
General & Plastic Surgery · 114d
Cleared Sep 11, 2006
ENDOFAST RELIANT SYSTEM
K060329
Endogun Medical Systems
General & Plastic Surgery · 214d