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510(k) K243843

Tendon Protect (50242) by Kerecis Limited — Product Code OWY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 4, 2025
Date Received
December 13, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon
Device Class
Class II
Regulation Number
878.3300
Review Panel
OR
Submission Type

For reinforcement of soft tissue where weakness exists in tendon repair.

Other clearances by Kerecis Limited

  • K251845 — Marigen Wound Extra; Kerecis Silicone; Kerecis Parvus (July 16, 2025)
  • K251844 — Kerecis SurgiBind (50241) (July 15, 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)
  • K153364 — Kerecis SecureMesh (August 19, 2016)
  • K132343 — MARIGEN WOUND DRESSING (October 23, 2013)

Other clearances for product code OWY

  • K251690 — Arthrex SpeedFLEX™ Implant (September 30, 2025)
  • K252647 — Tapestry Biointegrative Implant (September 19, 2025)
  • K250109 — TYBR Collagen Gel (June 6, 2025)
  • K242631 — REGENETEN™ Bioinductive Implant (November 26, 2024)
  • K222501 — Regeneten Bioinductive Implant (May 11, 2023)
  • K220867 — Tapestry Biointegrative Implant (May 23, 2022)
  • K212306 — Tapestry Biointegrative Implant (November 2, 2021)
  • K201572 — TAPESTRY Biointegrative Implant (October 19, 2020)
  • K151083 — BioBridge Collagen Matrix (January 8, 2016)
  • K140300 — COLLAGEN TENDON SHEET-DDI (CTS-DDI) (March 26, 2014)