Home / 510(k) Clearances / K173333

510(k) K173333

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 5, 2018
Date Received
October 23, 2017
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 & Associates, Inc.

  • K250410 — GORE® Tri-Lobe Balloon Catheter (June 2, 2025)
  • K240083 — GORE® PROPATEN® Vascular Graft (March 1, 2024)
  • K232312 — GORE® PROPATEN® Vascular Graft (January 9, 2024)
  • K233551 — GORE® ACUSEAL Vascular Graft (December 19, 2023)
  • K231505 — GORE® ACUSEAL Vascular Graft (June 23, 2023)
  • K191773 — GORE BIO-A Tissue Reinforcement (July 31, 2019)
  • K181940 — GORE SEAMGUARD Bioabsorbable Staple Line Reinforcement (August 17, 2018)
  • K163576 — GORE SYNECOR Preperitoneal Biomaterial (May 11, 2017)
  • K170740 — GORE VIABIL Short Wire Biliary Endoprosthesis (May 8, 2017)
  • K163217 — GORE BIO-A Tissue Reinforcement (February 10, 2017)

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)
  • K222919 — GORE® ENFORM Biomaterial (December 19, 2022)
  • K172545 — SERI Contour (September 22, 2017)
  • K163217 — GORE BIO-A Tissue Reinforcement (February 10, 2017)
  • K123128 — SERI SURGICAL SCAFFOLD (April 25, 2013)