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
49–72 of 336
Cleared Dec 22, 2016
DynaMesh-VENTRAL
K161550
Feg Textiltechnik Forschungs- Und Entwicklungsgesellschaft
General & Plastic Surgery · 202d
Cleared Jun 16, 2016
Endoform Reconstructive Template
K153632
Aroa Biosurgery Limited (Formerly Mesynthes Limited)
General & Plastic Surgery · 181d
Cleared May 13, 2016
Small PerFix Light Plug with 6 x 13.5 cm HydroLight onlay, Medium PerFix Light Plug with 6 x 13.5 cm HydroLight onlay, Large PerFix Light Plug with 6 x 13.5 cm HydroLight onlay, Extra Large PerFix Light Plug with 6 x 13.5 cm HydroLight onlay
K153236
C.R. Bard, Inc.
General & Plastic Surgery · 186d
Cleared Dec 11, 2015
GORE SYNECOR Biomaterial
K152609
W.L. Gore & Associates, Inc.
General & Plastic Surgery · 88d
Cleared Nov 17, 2015
TYRX Neuro Antibacterial Envelope
K152678
Tyrx, Inc.
General & Plastic Surgery · 60d
Cleared Oct 22, 2015
C-QUR, C-QUR FX, C-QUR TacShield, C-QUR V-Patch, C-QUR CentriFX, C-QUR Mosaic
K151386
Atrium Medical Corporation
General & Plastic Surgery · 149d
Cleared Sep 18, 2015
ECHO 2.0 LAP SYSTEM with VENTRALIGHT ST MESH
K143743
C.R. Bard, Inc.
General & Plastic Surgery · 261d
Cleared Aug 27, 2015
ProLite Mesh, ProLite Ultra Mesh, ProLoop Mesh Plug
K151437
Atrium Medical Corporation
General & Plastic Surgery · 90d
Cleared Jul 24, 2015
ULTRAPRO ADVANCED Macroporous Partically Absorbable Mesh
K150906
Ehicon, Inc.
General & Plastic Surgery · 112d
Cleared May 26, 2015
Versatex Monofilament Mesh
K150091
Sofradim Production
General & Plastic Surgery · 130d
Cleared May 07, 2015
Insightra Freedom Ventral Hernia Repair System
K142192
Insightra Medical
General & Plastic Surgery · 269d
Cleared Mar 27, 2015
TYRX Neuro Absorbable Antibacterial Envelope
K150291
Medtronic Tyrx, Inc.
General & Plastic Surgery · 49d
Cleared Mar 25, 2015
Modified ONFLEX Mesh
K142706
C.R. Bard, Inc.
General & Plastic Surgery · 184d
Cleared Mar 20, 2015
ONFLEX Mesh
K142711
C.R. Bard, Inc.
General & Plastic Surgery · 179d
Cleared Mar 13, 2015
Progrip Laparoscopic Self-Fixating Mesh
K143386
Sofradim Production
General & Plastic Surgery · 107d
Cleared Dec 31, 2014
TYRX Neuro Absorbable Antibacterial Envelope
K142611
Medtronic Tyrx, Inc.
General & Plastic Surgery · 106d
Cleared Nov 14, 2014
Parietex Monofilament Polyester Mesh (new name: Parietex Lightweight Mesh), Parietex Composite Mono PM Mesh (new name: Parietex Composite Parastomal Mesh), Parietex Composite Ventral Patch, Symbotex Composite Mesh
K142908
Sofradim Production
General & Plastic Surgery · 39d
Cleared Oct 28, 2014
Parietex Progrip Mesh (new name: Progrip Self-Gripping Polyester Mesh), Parietex Plug and Patch (new name : Parietex Plug and Patch System), Progrip Laparoscopic Self-Fixating Mesh
K142900
Sofradim Production
General & Plastic Surgery · 22d
Cleared Oct 23, 2014
ETHICON PHYSIOMESH OPEN FLEXIBLE COMPOSITE MESH DEVICE
K141560
Ethicon, Inc.
General & Plastic Surgery · 133d
Cleared Oct 17, 2014
PARIETENE MACROPOROUS MESH
K142091
Sofradim Production
General & Plastic Surgery · 77d
Cleared Sep 04, 2014
PREMIUM
K133889
Cousin Biotech Sas
General & Plastic Surgery · 258d
Cleared Aug 06, 2014
X-REPAIR
K141394
Synthasome
General & Plastic Surgery · 70d
Cleared Jul 02, 2014
X-REPAIRSL
K141499
Synthasome, Inc.
General & Plastic Surgery · 26d
Cleared Jun 10, 2014
FREEDOM INGUINAL HERNIA REPAIR IMPLANT-25MM/40MM/40MM WITH EXTENDED DISK
K140967
Insightra Medical
General & Plastic Surgery · 57d