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510(k) K153364

Kerecis SecureMesh by Kerecis Limited — Product Code OXE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 19, 2016
Date Received
November 20, 2015
Clearance Type
Traditional
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.

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  • K243843 — Tendon Protect (50242) (June 4, 2025)
  • K241080 — Kerecis Parvus (50207) (August 21, 2024)
  • K213231 — Kerecis Silicone (June 29, 2022)
  • K202430 — Kerecis Reconstruct (May 2, 2021)
  • K192612 — Kerecis Gingiva Graft (November 13, 2020)
  • K190528 — MariGen Wound Extra (July 10, 2019)
  • K132343 — MARIGEN WOUND DRESSING (October 23, 2013)

Other clearances for product code OXE

  • K170945 — Biodesign Staple Line Reinforcement (April 28, 2017)
  • K030879 — VERITAS COLLAGEN MATRIX (April 24, 2003)
  • K022044 — SURGISIS STAPLE LINE REINFORCEMENT (August 23, 2002)