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510(k) K143380

Phasix ST Mesh by C.R. Bard, Inc. — Product Code OWT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 5, 2015
Date Received
November 25, 2014
Clearance Type
Traditional
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.

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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)
  • K191773 — GORE BIO-A Tissue Reinforcement (July 31, 2019)
  • 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)
  • K120728 — PHASIX PLUG AND PATCH (October 22, 2012)
  • K101287 — TEPHAFLEX COMPOSITE MESH (August 30, 2010)
  • K033671 — GORE BIOABSORBABLE MESH (December 31, 2003)