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510(k) K222919

GORE® ENFORM Biomaterial by W. L. Gore and Associates, Inc. — Product Code OXF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 19, 2022
Date Received
September 26, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Mesh, Surgical, Absorbable, 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 W. L. Gore and Associates, Inc.

  • K180919 — GORE Tri-Lumen Catheter (October 5, 2018)
  • K172567 — GORE Molding and Occlusion Balloon Catheter (January 31, 2018)

Other clearances for product code OXF

  • K251224 — Restrata Soft Tissue Reinforcement (STR) (June 20, 2025)
  • K243302 — 3DMatrix DynaFlex (DynaFlex) (May 21, 2025)
  • K232602 — 3DMatrix Surgical Mesh (May 23, 2024)
  • K173333 — GORE ENFORM Biomaterial (April 5, 2018)
  • K172545 — SERI Contour (September 22, 2017)
  • K163217 — GORE BIO-A Tissue Reinforcement (February 10, 2017)
  • K123128 — SERI SURGICAL SCAFFOLD (April 25, 2013)