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
121–144 of 337
Cleared Apr 22, 2010
TORNIER SURGICAL MESH
K093799
Tornier, Inc.
General & Plastic Surgery · 133d
Cleared Apr 21, 2010
VENTRIO HERNIA PATCH
K100229
C.R. Bard, Inc.
General & Plastic Surgery · 85d
Cleared Apr 09, 2010
ETHICON PHYSIOMESH, FLEXIBLE COMPOSITE MESH
K093932
Ethicon GmbH
General & Plastic Surgery · 108d
Cleared Mar 26, 2010
PIVIT A/B ST AND PIVIT A/B ST-R
K093524
Tyrx, Inc.
General & Plastic Surgery · 130d
Cleared Mar 05, 2010
REFINE SUPPORT SYSTEM, MODEL 100.0100
K092538
Alure Medical, Inc.
General & Plastic Surgery · 198d
Cleared Jan 26, 2010
ATRIUM C-QUR OVT MESH
K100076
Atrium Medical Corp.
General & Plastic Surgery · 14d
Cleared Jan 25, 2010
TIGR SURGICAL MESH , MODEL WK-6
K092224
Novus Scientific Pte, Ltd.
General & Plastic Surgery · 186d
Cleared Jan 14, 2010
HYDROCOAT MESH
K090271
Promethean Surgical Devices, Inc.
General & Plastic Surgery · 344d
Cleared Dec 08, 2009
BARD PERFIX LIGHT PLUG, MODELS 0117050, 0117060, 0117070, 0117080, 0117150, 0117160
K092032
Davol Inc., Sub. C. R. Bard, Inc.
General & Plastic Surgery · 155d
Cleared Dec 07, 2009
WITTMANN PATCH
K093166
Aperta, LLC
General & Plastic Surgery · 62d
Cleared Aug 03, 2009
BARD 3DMAX LIGHT MESH, MODELS: 0117310, 0117311, 0117312, 0117320, 0117321, 011732
K091659
C.R. Bard, Inc.
General & Plastic Surgery · 55d
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 11, 2009
REFINE LIFT SYSTEM
K083102
Alure Medical, Inc.
General & Plastic Surgery · 203d
Cleared May 06, 2009
PARIETEX MONOFILAMENT POLYESTER MESH
K090858
Sofradim Production
General & Plastic Surgery · 37d
Cleared May 05, 2009
ORTHADAPT PR
K090288
Pegasus Biologics, Inc.
General & Plastic Surgery · 89d
Cleared Apr 23, 2009
REBOUND HRDV
K083467
Minnesota Medical Development, Inc.
General & Plastic Surgery · 150d
Cleared Mar 27, 2009
GORE BIO-A FISTULA PLUG
K083266
W.L. Gore & Associates, Inc.
General & Plastic Surgery · 142d
Cleared Mar 27, 2009
SYNTHASOME X-REPAIR
K083307
Synthasome, Inc.
General & Plastic Surgery · 137d
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 Jan 07, 2009
BIOMERIX COMPOSITE SURGICAL MESH, MODEL SMNR-0510 AND SMNR-1215
K082941
Biomerix Corporation
General & Plastic Surgery · 97d
Cleared Nov 13, 2008
SERISCAFFOLD SURGICAL MESH
K080442
Serica Technologies, Inc.
General & Plastic Surgery · 268d