Home / 510(k) Clearances / K172636

510(k) K172636

VitaMESH Macroporous PP Surgical Mesh by Proxy Biomedical , Ltd. — Product Code FTL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 30, 2018
Date Received
September 1, 2017
Clearance Type
Traditional
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 Proxy Biomedical , Ltd.

  • K111121 — VITAMESH (TM) BLUE LIGHTWEIGHT MACROPOROUS PP SURGICAL MESH (May 13, 2011)
  • K060520 — VITAMESH MACROPOROUS PP SURGICAL MESH (March 28, 2006)
  • K052100 — MODIFICATION TO MOTIFMESH SOFT TISSUE PATCH (August 11, 2005)
  • K051245 — POLYFORM SYNTHETIC MESH (June 17, 2005)
  • K050678 — MOTIFMESH SOFT TISSUE PATCH (May 20, 2005)

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)