Chrysalis Intelligence · Product Codes · FTL

FTL · Mesh, Surgical, Polymeric

General, Plastic Surgery · 26 clearances · 12 unique sponsors

Device class
Class II
Regulation 878.3300
Total clearances
26
2020-03-27 → 2026-05-21
Last 12 months
2
Unique sponsors
12
Medical specialty
General, Plastic Surgery
Review panel
SU
Regulation number
878.3300
Implant
Y
Life-sustain / support
N
GMP exempt
N
Third-party review
N
Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor Clearances Last 12 mo Most recent
Sofradim Production 6 1 2026-05-21
Deep Blue Medical Advances, Inc. 4 0 2023-10-18
Davol Inc., Subsidiary of C. R. Bard, Inc. 3 0 2025-07-24
Xiros, Ltd. 3 0 2023-05-31
Medtronic, Inc. 2 0 2020-04-08
Davol, Inc. 2 0 2025-06-12
Ariste Medical, LLC 1 0 2022-03-18
Medtronic - Sofradim Production 1 1 2025-10-24
ETHICON, Inc. 1 0 2020-08-06
Covidien 1 0 2022-09-22
C.R. Bard, Inc. 1 0 2020-07-17
Mast Biosurgery 1 0 2021-01-07
Reimbursement

Likely billing codes (AI-inferred · verify with billing)

Healthcare providers using this device would typically bill under these HCPCS Level II (alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku; official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available. Always verify with billing/coding teams before relying on these.

CodeTypeDescriptionConfidenceRationale
15777 CPT Medium Implantation of synthetic polymeric surgical mesh for reinforcement
A4649 HCPCS Surgical supply; miscellaneous ✓ CMS-verified description Medium Surgical mesh supply code
Pulse

Most recent 510(k) clearances

DateK-numberSponsorDevice
2026-05-21 K253956 Sofradim Production ProGrip™ advanced self-gripping polypropylene mesh (ADG1510, ADG2015, ADG3020, ADG4030)
2025-10-24 K253125 Medtronic - Sofradim Production Parietene™ Flat Sheet Mesh
2025-07-24 K251955 Davol Inc., Subsidiary of C. R. Bard, Inc. Onflex™ Mesh
2025-06-12 K251557 Davol, Inc. Bard® Mesh; Bard® Mesh Pre-Shaped
2025-04-23 K250869 Sofradim Production Parietene™ Macroporous Mesh (PPM5050 )
2025-04-09 K250098 Davol, Inc. Bard Soft Mesh; Bard Soft Mesh Pre-Shaped
2025-01-17 K243315 Sofradim Production ProGrip™ Self-Gripping Polypropylene Mesh
2024-06-14 K241250 Davol Inc., Subsidiary of C. R. Bard, Inc. 3DMax Light Mesh
2024-01-18 K232373 Sofradim Production Progrip™ Self-Gripping Polypropylene Mesh
2023-11-01 K233402 Davol Inc., Subsidiary of C. R. Bard, Inc. Bard 3DMax Mesh
2023-10-18 K232924 Deep Blue Medical Advances, Inc. T-Line® Hernia Mesh
2023-05-31 K230671 Xiros, Ltd. Pitch PaSoft Tissue Reinforcement Device
2023-02-23 K230227 Deep Blue Medical Advances, Inc. T-Line Hernia Mesh
2022-12-02 K223218 Sofradim Production Parietene Macroporous Mesh
2022-11-28 K221556 Deep Blue Medical Advances, Inc. T-Line Hernia Mesh
2022-09-22 K220540 Covidien ProGrip Self-Gripping Polypropylene Mesh
2022-08-26 K220091 Xiros, Ltd. Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device
2022-06-22 K220586 Sofradim Production Symbotex Composite Mesh, ProGrip Self-Gripping Polyester Mesh, Parietex Hydrophilic 2D 3D Anatomical Mesh, Versatex Monofilament Mesh
2022-03-18 K211132 Ariste Medical, LLC ARISTE AB Mesh
2021-08-13 K211563 Xiros, Ltd. Pitch-Patchs
2021-01-07 K200918 Mast Biosurgery SurgiWrap FROST
2020-08-06 K201143 ETHICON, Inc. VICRYL Mesh
2020-07-17 K200818 C.R. Bard, Inc. 3DMax MID Anatomical Mesh
2020-04-08 K192636 Medtronic, Inc. TYRX Neuro Absorbable Antibacterial Envelope (Medium), TYRX Neuro Absorbable Antibacterial Envelope (Large)
2020-03-30 K193144 Deep Blue Medical Advances, Inc. T-Line Hernia Mesh