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510(k) K220586

Symbotex Composite Mesh, ProGrip Self-Gripping Polyester Mesh, Parietex Hydrophilic 2D 3D Anatomical Mesh, Versatex Monofilament Mesh by Sofradim Production — Product Code FTL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 22, 2022
Date Received
March 1, 2022
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Mesh, Surgical, Polymeric
Device Class
Class II
Regulation Number
878.3300
Review Panel
SU
Submission Type

Other clearances by Sofradim Production

  • K250869 — Parietene™ Macroporous Mesh (PPM5050 ) (April 23, 2025)
  • K243315 — ProGrip™ Self-Gripping Polypropylene Mesh (January 17, 2025)
  • K233661 — Transorb™ Self-Gripping Resorbable Mesh (February 13, 2024)
  • K232373 — Progrip™ Self-Gripping Polypropylene Mesh (January 18, 2024)
  • K223218 — Parietene Macroporous Mesh (December 2, 2022)
  • K192443 — Dextile Anatomical Mesh (December 6, 2019)
  • K173796 — Parietex Surgical Mesh (modified into Parietex Hydrophilic 2D, 3D, Anatomical Me (March 9, 2018)
  • K172395 — Duatene bilayer mesh (February 1, 2018)
  • K163212 — Parietene DS Composite Mesh (June 29, 2017)
  • K150091 — Versatex Monofilament Mesh (May 26, 2015)

Other clearances for product code FTL

  • K253125 — Parietene™ Flat Sheet Mesh (October 24, 2025)
  • K251955 — Onflex™ Mesh (July 24, 2025)
  • K251557 — Bard® Mesh; Bard® Mesh Pre-Shaped (June 12, 2025)
  • K250869 — Parietene™ Macroporous Mesh (PPM5050 ) (April 23, 2025)
  • K250098 — Bard Soft Mesh; Bard Soft Mesh Pre-Shaped (April 9, 2025)
  • K243315 — ProGrip™ Self-Gripping Polypropylene Mesh (January 17, 2025)
  • K241250 — 3DMax Light Mesh (June 14, 2024)
  • K232373 — Progrip™ Self-Gripping Polypropylene Mesh (January 18, 2024)
  • K233402 — Bard 3DMax Mesh (November 1, 2023)
  • K232924 — T-Line® Hernia Mesh (October 18, 2023)