Home / 510(k) Clearances / K171817

510(k) K171817

Biodesign Diaphragmatic Hernia Graft by Cook Biotech Incorporated — Product Code FTM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 13, 2018
Date Received
June 19, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

Other clearances by Cook Biotech Incorporated

  • K232646 — Biodesign Otologic Butterfly Graft (ENT-OTO-BFLY-0.4-0.6); Biodesign Otologic Bu (May 24, 2024)
  • K201000 — Biodesign Staple Line Reinforcement (July 13, 2020)
  • K191696 — Biodesign Anal Fistula Plug, Biodesign Fistula Plug, Biodesign Plastic Surgery M (December 27, 2019)
  • K162934 — Biodesign Parastomal Hernia Repair Graft (July 10, 2017)
  • K170016 — Biodesign Fistula Plug (June 21, 2017)
  • K170945 — Biodesign Staple Line Reinforcement (April 28, 2017)
  • K161762 — DynaMatrix/Dynamatrix Plus (January 13, 2017)
  • K162741 — AxoGuard Nerve Connector (October 31, 2016)
  • K160136 — Flowable Wound Matrix (September 28, 2016)
  • K161221 — Biodesign Sling, Biodesign Plastic Surgery Matrix, Biodesign Anal Fistula Plug (May 26, 2016)

Other clearances for product code FTM

  • K250598 — Endoform Reconstructive Template - PLGA (June 3, 2025)
  • K243595 — OviTex PRS (Long-Term Resorbable) (December 19, 2024)
  • K233991 — CanGaroo RM Antibacterial Envelope (June 14, 2024)
  • K241126 — OviTex PRS (May 22, 2024)
  • K223052 — Peri-Guard and Supple Peri-Guard (April 7, 2023)
  • K214070 — OviTex PRS (Long Term Resorbable) (March 21, 2023)
  • K213163 — VersaWrap (October 29, 2021)
  • K213125 — PERI-STRIPS Dry Staple Line Reinforcement with VERITAS Collagen Matrix with SECU (October 27, 2021)
  • K203496 — Nexo-Gide Bilayer Collagen Membrane (July 14, 2021)
  • K203600 — VersaWrap (March 9, 2021)