Home / 510(k) Clearances / K142887

510(k) K142887

SIS Inguinal Hernia Repair Graft by Cook Biotech Incorprated — Product Code FTM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 1, 2015
Date Received
October 2, 2014
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 Incorprated

  • K150668 — Biodesign Enterocutaneous Fistula Plug (December 9, 2015)
  • K150594 — Biodesign Otologic Repair Graft (September 16, 2015)
  • K121360 — BIODESIGN ENT REPAIR GRAFT (February 27, 2013)

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)