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510(k) K163217

GORE BIO-A Tissue Reinforcement by W.L. Gore & Associates, Inc. — Product Code OXF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 10, 2017
Date Received
November 16, 2016
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.

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  • 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)
  • K173333 — GORE ENFORM Biomaterial (April 5, 2018)
  • K163576 — GORE SYNECOR Preperitoneal Biomaterial (May 11, 2017)
  • K170740 — GORE VIABIL Short Wire Biliary Endoprosthesis (May 8, 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)
  • K173333 — GORE ENFORM Biomaterial (April 5, 2018)
  • K172545 — SERI Contour (September 22, 2017)
  • K123128 — SERI SURGICAL SCAFFOLD (April 25, 2013)