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
193–216 of 337
Cleared Jul 26, 2006
TRULENE MESH
K060018
Sutures India Pvt., Ltd.
General & Plastic Surgery · 203d
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 Jul 14, 2006
TYRX ANTIMICROBIAL MESH
K053656
Tyrx Pharma, Inc.
General & Plastic Surgery · 196d
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 Mar 28, 2006
VITAMESH MACROPOROUS PP SURGICAL MESH
K060520
Proxy Biomedical , Ltd.
General & Plastic Surgery · 29d
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 19, 2006
SPORTMESH
K052830
Artimplant AB
General & Plastic Surgery · 106d
Cleared Jan 18, 2006
OPTILENE MESH LP
K053158
Aesculap, Inc.
General & Plastic Surgery · 65d
Cleared Dec 22, 2005
TYRX SURGICAL MESH, MODEL SMPC-0501
K052864
Tyrx Pharma, Inc.
General & Plastic Surgery · 72d
Cleared Dec 19, 2005
SEPRAMESH IP BIORESORBABLE COATING/PERMANENT MESH
K053066
Genzyme Corporation
General & Plastic Surgery · 48d
Cleared Dec 07, 2005
GORE SEAMGUARD STAPLE LINE REINFORCEMENT MATERIAL
K053200
W.L. Gore & Associates, Inc.
General & Plastic Surgery · 21d
Cleared Dec 07, 2005
GORE SEAMGUARD BIOABSORBABLE STAPLE LINE REINFORCEMENT MATERIAL
K053202
W.L. Gore & Associates
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 Aug 11, 2005
MODIFICATION TO MOTIFMESH SOFT TISSUE PATCH
K052100
Proxy Biomedical , Ltd.
General & Plastic Surgery · 8d
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