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510(k) K251844

Kerecis SurgiBind (50241) by Kerecis Limited — Product Code OXH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 15, 2025
Date Received
June 16, 2025
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Mesh, Surgical, Collagen, Plastic And Reconstructive Surgery
Device Class
Class II
Regulation Number
878.3300
Review Panel
SU
Submission Type

For reinforcement of soft tissue where weakness exists in plastic and reconstructive surgery.

Other clearances by Kerecis Limited

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

Other clearances for product code OXH

  • K202430 — Kerecis Reconstruct (May 2, 2021)
  • K171357 — SurgiMend PRS Meshed, Revize-X (June 7, 2017)
  • K160400 — Miromatrix Biological Mesh (June 8, 2016)
  • K150341 — Miromatrix Biological Mesh RS (May 12, 2015)