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
Declining activity - 7 submissions in the last 2 years vs 10 in the prior period
Review times improving: avg 63d recently vs 120d historically

FDA 510(k) Cleared Mesh, Surgical, Polymeric Devices (Product Code FTL)

336 devices
1–24 of 336
Cleared May 21, 2026
ProGrip™ advanced self-gripping polypropylene mesh (ADG1510, ADG2015, ADG3020, ADG4030)
K253956
Sofradim Production
General & Plastic Surgery · 162d
Cleared Oct 24, 2025
Parietene™ Flat Sheet Mesh
K253125
Medtronic - Sofradim Production
General & Plastic Surgery · 29d
Cleared Jul 24, 2025
Onflex™ Mesh
K251955
Davol Inc., Subsidiary of C. R. Bard, Inc.
General & Plastic Surgery · 29d
Cleared Jun 12, 2025
Bard® Mesh
K251557
Davol, Inc.
General & Plastic Surgery · 22d
Cleared Apr 23, 2025
Parietene™ Macroporous Mesh (PPM5050 )
K250869
Sofradim Production
General & Plastic Surgery · 30d
Cleared Apr 09, 2025
Bard Soft Mesh
K250098
Davol, Inc.
General & Plastic Surgery · 85d
Cleared Jan 17, 2025
ProGrip™ Self-Gripping Polypropylene Mesh
K243315
Sofradim Production
General & Plastic Surgery · 87d
Cleared Jun 14, 2024
3DMax Light Mesh
K241250
Davol Inc., Subsidiary of C. R. Bard, Inc.
General & Plastic Surgery · 42d
Cleared Jan 18, 2024
Progrip™ Self-Gripping Polypropylene Mesh
K232373
Sofradim Production
General & Plastic Surgery · 163d
Cleared Nov 01, 2023
Bard 3DMax Mesh
K233402
Davol Inc., Subsidiary of C. R. Bard, Inc.
General & Plastic Surgery · 28d
Cleared Oct 18, 2023
T-Line® Hernia Mesh
K232924
Deep Blue Medical Advances, Inc.
General & Plastic Surgery · 29d
Cleared May 31, 2023
Pitch PaSoft Tissue Reinforcement Device
K230671
Xiros, Ltd.
General & Plastic Surgery · 82d
Cleared Feb 23, 2023
T-Line Hernia Mesh
K230227
Deep Blue Medical Advances, Inc.
General & Plastic Surgery · 27d
Cleared Dec 02, 2022
Parietene Macroporous Mesh
K223218
Sofradim Production
General & Plastic Surgery · 46d
Cleared Nov 28, 2022
T-Line Hernia Mesh
K221556
Deep Blue Medical Advances, Inc.
General & Plastic Surgery · 181d
Cleared Sep 22, 2022
ProGrip Self-Gripping Polypropylene Mesh
K220540
Covidien
General & Plastic Surgery · 209d
Cleared Aug 26, 2022
Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device
K220091
Xiros, Ltd.
General & Plastic Surgery · 226d
Cleared Jun 22, 2022
Symbotex Composite Mesh, ProGrip Self-Gripping Polyester Mesh, Parietex Hydrophilic 2D 3D Anatomical Mesh, Versatex Monofilament Mesh
K220586
Sofradim Production
General & Plastic Surgery · 113d
Cleared Mar 18, 2022
ARISTE AB Mesh
K211132
Ariste Medical, LLC
General & Plastic Surgery · 336d
Cleared Aug 13, 2021
Pitch-Patchs
K211563
Xiros, Ltd.
General & Plastic Surgery · 85d
Cleared Jan 07, 2021
SurgiWrap FROST
K200918
Mast Biosurgery
General & Plastic Surgery · 276d
Cleared Aug 06, 2020
VICRYL Mesh
K201143
Ethicon, Inc.
General & Plastic Surgery · 99d
Cleared Jul 17, 2020
3DMax MID Anatomical Mesh
K200818
C.R. Bard, Inc.
General & Plastic Surgery · 109d
Cleared Apr 08, 2020
TYRX Neuro Absorbable Antibacterial Envelope (Medium), TYRX Neuro Absorbable Antibacterial Envelope (Large)
K192636
Medtronic, Inc.
General & Plastic Surgery · 198d

About Product Code FTL - Regulatory Context

510(k) Submission Activity

336 total 510(k) submissions under product code FTL since 1979, with 336 receiving FDA clearance (average review time: 118 days).

Submission volume has declined in recent years - 7 submissions in the last 24 months compared to 10 in the prior period.

FDA 510(k) Review Time - FTL Product Code

Recent submissions under FTL have taken an average of 63 days to reach a decision - down from 120 days historically, suggesting improved FDA processing for this classification.

FTL devices are reviewed by the General & Plastic Surgery panel. Browse all General & Plastic Surgery devices →