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510(k) K170945

Biodesign Staple Line Reinforcement by Cook Biotech Incorporated — Product Code OXE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 28, 2017
Date Received
March 30, 2017
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Mesh, Surgical, Collagen, Staple Line Reinforcement
Device Class
Class II
Regulation Number
878.3300
Review Panel
SU
Submission Type

For reinforcement of soft tissue where weakness exists during staple line reinforcement procedures.

Other clearances by Cook Biotech Incorporated

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  • K201000 — Biodesign Staple Line Reinforcement (July 13, 2020)
  • K191696 — Biodesign Anal Fistula Plug, Biodesign Fistula Plug, Biodesign Plastic Surgery M (December 27, 2019)
  • K171817 — Biodesign Diaphragmatic Hernia Graft (March 13, 2018)
  • K162934 — Biodesign Parastomal Hernia Repair Graft (July 10, 2017)
  • K170016 — Biodesign Fistula Plug (June 21, 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 OXE

  • K153364 — Kerecis SecureMesh (August 19, 2016)
  • K030879 — VERITAS COLLAGEN MATRIX (April 24, 2003)
  • K022044 — SURGISIS STAPLE LINE REINFORCEMENT (August 23, 2002)