Home / 510(k) Clearances / K181935

510(k) K181935

Endoform Reconstructive Template - Non Absorbable by Aroa Biosurgery , Ltd. — Product Code FTL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 4, 2018
Date Received
July 19, 2018
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 Aroa Biosurgery , Ltd.

  • K250598 — Endoform Reconstructive Template - PLGA (June 3, 2025)
  • K231305 — Endoform Dental Membrane (January 23, 2024)
  • K223373 — Enivo™ (April 7, 2023)
  • K200502 — Myriad Particles (March 31, 2021)
  • K200413 — Symphony (July 29, 2020)
  • K183398 — Endoform Restella (April 11, 2019)
  • K172318 — Endoform Silver Dermal Template (November 17, 2017)
  • K171231 — Endoform Topical Matrix (June 14, 2017)

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)