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510(k) K190185

Phasix ST Mesh with Open Positioning System by C.R. Bard, Inc. — Product Code OWT

K190185 is an FDA 510(k) premarket notification submitted by C.R. Bard, Inc. for the device "Phasix ST Mesh with Open Positioning System". The FDA issued a decision of Substantially Equivalent on June 12, 2019. The device falls under product code OWT (Mesh, Surgical, Absorbable, Abdominal Hernia), a Class II device regulated under 21 CFR 878.3300. C.R. Bard, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 12, 2019
Date Received
February 1, 2019
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 by C.R. Bard, Inc.

  • K253514 — Minnesota Four-Lumen Esophagogastric Tamponade Tube - 18 French (0092220); Blake (July 10, 2026)
  • K254076 — BD Touchless™ Plus Unisex Pre-Lubricated Urethral Catheter Kit (May 29, 2026)
  • K252971 — Elyra™ Thulium Fiber Laser System and Elyra™ Plus Thulium Fiber Laser System (La (March 17, 2026)
  • K251864 — Rubber Utility Catheter (February 23, 2026)
  • K251186 — Bard® Temporary Pacing Electrode Catheter Needle / Cannula (Introducer) (May 15, 2025)
  • K241334 — Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Elec (January 31, 2025)
  • K230356 — Aspirex™ Thrombectomy System (March 31, 2023)
  • K223177 — Highlander™ 014 PTA Balloon Dilatation Catheter (January 20, 2023)
  • K222793 — WavelinQ™ Generator (October 17, 2022)
  • K220270 — Aspirex Thrombectomy System (June 21, 2022)

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)
  • 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