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 W.L. Gore & Associates, Inc., Sofradim Production and C.R. Bard, Inc..

336
Total
336
Cleared
118d
Avg days
1979
Since
336 devices
49–72 of 336
Cleared Sep 18, 2015
ECHO 2.0 LAP SYSTEM with VENTRALIGHT ST MESH
K143743
C.R. Bard, Inc.
General & Plastic Surgery · 261d
Cleared May 26, 2015
Versatex Monofilament Mesh
K150091
Sofradim Production
General & Plastic Surgery · 130d
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 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 May 30, 2014
ULTRAPRO COMFORT PLUG
K133198
Ethicon, Inc.
General & Plastic Surgery · 225d
Cleared May 07, 2014
PROGRIP SELF-GRIPPING POLYPROPYLENE MESH, PARIETENE FLAT SHEET MESH
K140941
Sofradim Production
General & Plastic Surgery · 23d
Cleared Dec 13, 2013
BARD VENTRALEX HERNIA PATCH
K132441
C.R. Bard, Inc.
General & Plastic Surgery · 129d
Cleared Aug 22, 2013
SYMBOTEX(TM) COMPOSITE MESH
K131969
Sofradim Production
General & Plastic Surgery · 55d
Cleared May 01, 2013
VENTRALIGHT ST MESH WITH ECHO PS POSITIONING SYSTEM
K130968
C.R. Bard, Inc.
General & Plastic Surgery · 23d
Cleared Dec 11, 2012
PROGRIP LAPAROSCOPIC SELF-FIXATING MESH
K123479
Sofradim Production
General & Plastic Surgery · 28d
Cleared Nov 02, 2012
COMPOSIX L/P MESH WITH ECHO PS POSITIONING SYSTEM VENTRALIGHT ST MESH WITH ECHO PS POSITIONING SYSTEM
K122436
C.R. Bard, Inc.
General & Plastic Surgery · 84d
Cleared Jul 20, 2012
VENTRIO LIGHT HERNIA PATCH WITH TRM ANTIMICROBIAL COATING
K113229
C.R. Bard, Inc.
General & Plastic Surgery · 261d
Cleared Jun 29, 2012
PROGRIP LAPARSCOPIC SELF-FIXATING MESH
K120897
Sofradim Production
General & Plastic Surgery · 95d
Cleared Jun 13, 2012
PARIETEX COMPOSITE VENTRAL PATCH
K120506
Sofradim Production
General & Plastic Surgery · 113d
Cleared Apr 26, 2012
C-QUR RPM MESH
K121070
Atrium Medical Corp.
General & Plastic Surgery · 17d
Cleared Jan 25, 2012
TORNIER COLLAGEN COATED BIOFIBER SCAFFOLD
K111337
Tornier, Inc.
General & Plastic Surgery · 258d
Cleared Nov 22, 2011
RENASYS AB ABOMINAL DRESSING KIT
K112784
Smith & Nephew, Inc.
General & Plastic Surgery · 57d
Cleared Aug 11, 2011
PAIRETEX OPTIMIZED COMPOSITE MESH (PCO-FX REFRENCES)
K110663
Sofradim Production
General & Plastic Surgery · 156d
Cleared May 10, 2011
TORNIER BIOFIBER SCAFFOLD
K102788
Tornier, Inc.
General & Plastic Surgery · 228d