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 C.R. Bard, Inc., Sofradim Production and Ethicon, Inc..

336
Total
336
Cleared
118d
Avg days
1979
Since
336 devices
25–48 of 336
Cleared Mar 30, 2020
T-Line Hernia Mesh
K193144
Deep Blue Medical Advances, Inc.
General & Plastic Surgery · 138d
Cleared Mar 27, 2020
TYRX Absorbable Antibacterial Envelope (medium), TYRX Absorbable Antibacterial Envelope (large)
K192389
Medtronic, Inc.
General & Plastic Surgery · 206d
Cleared Dec 06, 2019
Dextile Anatomical Mesh
K192443
Sofradim Production
General & Plastic Surgery · 91d
Cleared Oct 22, 2019
VICRYL Mesh
K191373
Ethicon, Inc.
General & Plastic Surgery · 152d
Cleared Sep 27, 2019
FlexBand Plus
K192112
International Life Sciences
General & Plastic Surgery · 53d
Cleared Sep 26, 2019
Exogenesis Hernia Mesh
K191545
Exogenesis Corporation
General & Plastic Surgery · 107d
Cleared Dec 14, 2018
Phasix ST Mesh with Echo 2 Positioning System
K182008
C.R. Bard, Inc.
General & Plastic Surgery · 140d
Cleared Dec 04, 2018
Endoform Reconstructive Template - Non Absorbable
K181935
Aroa Biosurgery , Ltd.
General & Plastic Surgery · 138d
Cleared Oct 31, 2018
DynaMesh-POSTERIOR
K182087
Feg Textiltechnik Forschungs- Und Entwicklungsgesellschaft
General & Plastic Surgery · 90d
Cleared Aug 02, 2018
Polydioxanone Surgical Scaffold
K181094
Lntegra Lifesciences
General & Plastic Surgery · 99d
Cleared Jul 26, 2018
PROLENE (Polypropylene) 3D Patch
K181268
Ethicon, Inc.
General & Plastic Surgery · 73d
Cleared Jul 02, 2018
ULTRAPRO Mesh and ULTRAPRO ADVANCED
K180910
Ethicon, Inc.
General & Plastic Surgery · 87d
Cleared Jun 28, 2018
PROLENE Polypropylene Mesh Non-Absorbable Synthetic Surgical Mesh, PROLENE (Polypropylene) Hernia System, Non-absorbable Synthetic Surgical Mesh
K180829
Ethicon, Inc.
General & Plastic Surgery · 90d
Cleared Jun 07, 2018
TYRX Neuro Absorbable Antibacterial Envelope (medium)
K180122
Medtronic, Inc.
General & Plastic Surgery · 142d
Cleared Apr 30, 2018
VitaMESH Macroporous PP Surgical Mesh
K172636
Proxy Biomedical , Ltd.
General & Plastic Surgery · 241d
Cleared Apr 24, 2018
TYRX Absorbable Antibacterial Envelope (medium), TYRX Absorbable Antibacterial Envelope (large)
K180030
Medtronic, Inc.
General & Plastic Surgery · 111d
Cleared Mar 09, 2018
Parietex Surgical Mesh (modified into Parietex Hydrophilic 2D, 3D, Anatomical Mesh), Parietex Composite Mesh (PCO and PCO-OS references), Parietex Optimized Composite Mesh (PCO-X, PCO-FX and PCO-OSX references)
K173796
Sofradim Production
General & Plastic Surgery · 85d
Cleared Feb 01, 2018
Duatene bilayer mesh
K172395
Sofradim Production
General & Plastic Surgery · 177d
Cleared Oct 05, 2017
PROLENE Soft Polypropylene Mesh
K172089
Ethicon, Inc.
General & Plastic Surgery · 86d
Cleared May 11, 2017
GORE SYNECOR Preperitoneal Biomaterial
K163576
W.L. Gore & Associates, Inc.
General & Plastic Surgery · 143d
Cleared Mar 11, 2017
PROLENE Soft Polypropylene Mesh
K163152
Ethicon, Inc.
General & Plastic Surgery · 121d
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 Sep 18, 2015
ECHO 2.0 LAP SYSTEM with VENTRALIGHT ST MESH
K143743
C.R. Bard, Inc.
General & Plastic Surgery · 261d
Cleared Mar 25, 2015
Modified ONFLEX Mesh
K142706
C.R. Bard, Inc.
General & Plastic Surgery · 184d