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
145–168 of 336
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 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 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 Jun 02, 2006
BARD EXTRA LARGE COMPOSIX KUGEL HERNIA PATCH
K061314
Davol Inc., Sub. C. R. Bard, Inc.
General & Plastic Surgery · 22d
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 Feb 22, 2006
POPMESH
K053424
Caldera Medical, Inc.
General & Plastic Surgery · 76d
Cleared Feb 22, 2006
CALDERA MESH
K060004
Caldera Medical, Inc.
General & Plastic Surgery · 50d
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 Aug 18, 2005
INCLOSE SURGICAL MESH SYSTEM
K050969
Anulex Technologies, Inc.
General & Plastic Surgery · 122d
Cleared Aug 11, 2005
ORTHOMEND
K051766
Tei Biosciences, Inc.
General & Plastic Surgery · 42d
Cleared May 27, 2005
SURGI-WRAP MAST BIORESORBABLE SHEET
K050332
Mast Biosurgery USA, Inc.
General & Plastic Surgery · 106d
Cleared May 20, 2005
MOTIFMESH SOFT TISSUE PATCH
K050678
Proxy Biomedical , Ltd.
General & Plastic Surgery · 65d
Cleared May 16, 2005
REPOL ANGIMESH, ANGIMESH PRE, FOLDED MESH, REPOL PLUG BASIC, REPOL PLUG CAP, REPOL PLUG FLOWER AND WINGS MESH
K043191
Angiologica B. M. Srl
General & Plastic Surgery · 180d
Cleared May 16, 2005
TISSUE FIXATION SYSTEM
K050418
Tfs Manufacturing Pty, Ltd.
General & Plastic Surgery · 87d