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510(k) K243241

Phasix ST Umbilical Hernia Patch by Davol, Inc., A Subsidiary of C.R. Bard, Inc. — Product Code OWT

K243241 is an FDA 510(k) premarket notification submitted by Davol, Inc., A Subsidiary of C.R. Bard, Inc. for the device "Phasix ST Umbilical Hernia Patch". The FDA issued a decision of Substantially Equivalent on February 19, 2025. The device falls under product code OWT (Mesh, Surgical, Absorbable, Abdominal Hernia), a Class II device regulated under 21 CFR 878.3300.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 19, 2025
Date Received
October 10, 2024
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.

Other clearances for product code OWT

  • 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)
  • 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