Phasix ST Mesh with Open Positioning System
FDA 510(k) K190185 · C.R. Bard, Inc.
510(k) numberK190185
Submission
- Device name
- Phasix ST Mesh with Open Positioning System
- Applicant
- C.R. Bard, Inc.
Warwick, RI, US - Received
- February 1, 2019
- Decision date
- June 12, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OWT – Mesh, Surgical, Absorbable, Abdominal Hernia
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.3300
- Specialty
- General, Plastic Surgery
- Implant
- Yes
For reinforcement of soft tissue where weakness exists during hernia repair.
Other 510(k)s with product code OWT
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K243241 | Phasix ST Umbilical Hernia PatchOWT · Traditional | Davol, Inc., A Subsidiary of C.R. Bard, Inc. | 02/19/2025SE |
| K233661 | Transorb Self-Gripping Resorbable MeshOWT · Traditional | Sofradim Production | 02/13/2024SE |
| K191749 | TIGR Matrix Surgical Mesh, TIGR Surgical MeshOWT · Traditional | Novus Scientific AB | 03/26/2020SE |
| K191773 | GORE BIO-A Tissue ReinforcementOWT · Special | W. L. Gore & Associates, Inc. | 07/31/2019SE |
| K173143 | Phasix ST MeshOWT · Traditional | C.R. Bard, Inc. | 04/25/2018SE |
| K163005 | TIGR Matrix Surgical MeshOWT · Traditional | Novus Scientific AB | 07/27/2017SE |
| K143380 | Phasix ST MeshOWT · Traditional | C.R. Bard, Inc. | 06/05/2015SE |
| K120728 | Phasix Plug and PatchOWT · Traditional | C.R. Bard, Inc. | 10/22/2012SE |
| K101287 | Tephaflex Composite MeshOWT · Traditional | Tepha, Inc. | 08/30/2010SE |
| K033671 | Gore Bioabsorbable MeshOWT · Traditional | W. L. Gore & Associates, Inc. | 12/31/2003SE |
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Questions and answers
When was Phasix ST Mesh with Open Positioning System cleared by the FDA?
Phasix ST Mesh with Open Positioning System (K190185) received a 510(k) decision of Substantially Equivalent on June 12, 2019, 131 days after the submission was received.
What is the product code of K190185?
The FDA product code is OWT – Mesh, Surgical, Absorbable, Abdominal Hernia, a Class II (moderate risk) device regulated under 21 CFR 878.3300.