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 Dec 22, 2004
GORE POLYPROPYLENE HERNIA MESH
K043081
W.L. Gore & Associates, Inc.
General & Plastic Surgery · 44d
Cleared Sep 10, 2004
BARD CK PARASTOMAL HERNIA PATCH, MODELS 0118001, 0118002, 0118003, 0118004
K042026
C.R. Bard, Inc.
General & Plastic Surgery · 44d
Cleared Apr 29, 2004
MODIFICATION TO PARIETEX COMPOSITE (PCO) MESH
K040998
Sofradim Production
General & Plastic Surgery · 10d
Cleared Apr 01, 2004
ULTRAPRO MESH
K033337
Ethicon, Inc.
General & Plastic Surgery · 167d
Cleared Mar 01, 2004
BARD SOFT MESH, MODELS 0117001, 0117002, 0117003, 0117004, 0117005, 0117006, 0117007
K033814
C.R. Bard, Inc.
General & Plastic Surgery · 83d
Cleared Jan 15, 2004
UGYTEX MESH
K033376
Sofradim Production
General & Plastic Surgery · 85d
Cleared Nov 28, 2003
GORE SEAMGUARD BIOABSORBABLE STAPLE LINE REINFORCEMENT MATERIAL
K032865
W.L. Gore & Associates, Inc.
General & Plastic Surgery · 77d
Cleared Sep 17, 2003
PROCEED TRILAMINATE SURGICAL MESH
K031925
Ethicon, Inc.
General & Plastic Surgery · 86d
Cleared Aug 15, 2003
GORE-TEX DUALMESH EMERGE PLUS BIOMATERIAL
K032168
W.L. Gore & Associates, Inc.
General & Plastic Surgery · 30d
Cleared Feb 26, 2003
V.A.C. ABDOMINAL DRESSING
K022011
Kinetic Concepts, Inc.
General & Plastic Surgery · 252d
Cleared Feb 20, 2003
SMALL BARD VENTRALEX PATCH
K024008
C.R. Bard, Inc.
General & Plastic Surgery · 78d
Cleared Sep 10, 2002
DUALMESH EMERGE & EMERGE PLUS BIOMATERIAL
K022782
W.L. Gore & Associates, Inc.
General & Plastic Surgery · 19d
Cleared Aug 23, 2002
BARD CRURASOFT PATCH, MODELS 0116003 & 0116001
K022350
C.R. Bard, Inc.
General & Plastic Surgery · 35d
Cleared Jul 16, 2002
BARD VENTRALEX HERNIA PATCH, MODELS 0010302, 0010301
K021736
C.R. Bard, Inc.
General & Plastic Surgery · 49d
Cleared Apr 27, 2001
PROLENE (POLYPROPYLENE) 3D PATCH, NONABSORBABLE SYNTHETIC SURGICAL MESH
K010722
Ethicon, Inc.
General & Plastic Surgery · 46d
Cleared Apr 04, 2001
IVS TUNNELLER
K010035
United States Surgical, A Division of Tyco Healthc
General & Plastic Surgery · 90d
Cleared Feb 21, 2001
GORE-TEX DUALMESH PLUS BIOMATERIAL WITH HOLES
K010228
W.L. Gore & Associates, Inc.
General & Plastic Surgery · 28d
Cleared Jan 24, 2001
SOFRADIM PARIETEX SURGICAL MESHES
K003990
Sofradim Production
General & Plastic Surgery · 29d
Cleared Jan 22, 2001
COMPOSIX KUGEL MESH, MODEL 0010201,0010202,0010203,0010204,0010205
K003323
Davol, Inc.
General & Plastic Surgery · 90d
Cleared Nov 29, 2000
AMS TRIANGLE SILICONE-COATED SLING AND SURGICAL MESH
K002721
American Medical Systems, Inc.
General & Plastic Surgery · 90d
Cleared Nov 22, 2000
VYPRO MESH, VICRYL PROLENE PARTIALLY ABSORBABLE SYNTHETIC SURGICAL MESH
K002672
Ethicon, Inc.
General & Plastic Surgery · 86d
Cleared Oct 11, 2000
COMPOSIX E/X MESH
K002684
C.R. Bard, Inc.
General & Plastic Surgery · 44d
Cleared Jul 24, 2000
ATRIUM LITE MESH
K002093
Atrium Medical Corp.
General & Plastic Surgery · 13d
Cleared May 23, 2000
PROLENE SOFT (POLYPROPYLENE), NONABSORBABALE SYNTHETIC SURGICAL MESH
K001122
Ethicon, Inc.
General & Plastic Surgery · 46d