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510(k) K191773

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

K191773 is an FDA 510(k) premarket notification submitted by W. L. Gore & Associates, Inc. for the device "GORE BIO-A Tissue Reinforcement". The FDA issued a decision of Substantially Equivalent on July 31, 2019. The device falls under product code OWT (Mesh, Surgical, Absorbable, Abdominal Hernia), a Class II device regulated under 21 CFR 878.3300. W. L. Gore & Associates, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 31, 2019
Date Received
July 2, 2019
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Mesh, Surgical, Absorbable, Abdominal Hernia
Device Class
Class II
Regulation Number
878.3300
Review Panel
SU
Submission Type

For reinforcement of soft tissue where weakness exists during hernia repair.

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)
  • K222919 — GORE® ENFORM Biomaterial (December 19, 2022)
  • K180919 — GORE Tri-Lumen Catheter (October 5, 2018)
  • K181940 — GORE SEAMGUARD Bioabsorbable Staple Line Reinforcement (August 17, 2018)
  • K173333 — GORE ENFORM Biomaterial (April 5, 2018)
  • K172567 — GORE Molding and Occlusion Balloon Catheter (January 31, 2018)

Other clearances for product code OWT

  • K243241 — Phasix ST Umbilical Hernia Patch (February 19, 2025)
  • K233661 — Transorb™ Self-Gripping Resorbable Mesh (February 13, 2024)
  • K191749 — TIGR Matrix Surgical Mesh, TIGR Surgical Mesh (March 26, 2020)
  • K190185 — Phasix ST Mesh with Open Positioning System (June 12, 2019)
  • K173143 — Phasix ST Mesh (April 25, 2018)
  • K163005 — TIGR Matrix Surgical Mesh (July 27, 2017)
  • K143380 — Phasix ST Mesh (June 5, 2015)
  • K120728 — PHASIX PLUG AND PATCH (October 22, 2012)
  • K101287 — TEPHAFLEX COMPOSITE MESH (August 30, 2010)
  • K033671 — GORE BIOABSORBABLE MESH (December 31, 2003)

FDA data resources