GORE BIO-A Tissue Reinforcement
FDA 510(k) K191773 · W. L. Gore & Associates, Inc.
510(k) numberK191773
Submission
- Device name
- GORE BIO-A Tissue Reinforcement
- Applicant
- W. L. Gore & Associates, Inc.
Elkton, MD, US - Received
- July 2, 2019
- Decision date
- July 31, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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.
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|---|---|---|---|
| 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 |
| K190185 | Phasix ST Mesh with Open Positioning SystemOWT · Traditional | C.R. Bard, Inc. | 06/12/2019SE |
| 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 |
More from W. L. Gore & Associates, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K250410 | GORE® Tri-Lobe Balloon CatheterDQY · Traditional | 06/02/2025SE |
| K240083 | GORE® PROPATEN® Vascular GraftDSY · Traditional | 03/01/2024SE |
| K232312 | GORE® PROPATEN® Vascular GraftDSY · Traditional | 01/09/2024SE |
| K233551 | GORE® ACUSEAL Vascular GraftDSY · Traditional | 12/19/2023SE |
| K231505 | GORE® ACUSEAL Vascular GraftDSY · Special | 06/23/2023SE |
| K181940 | GORE SEAMGUARD Bioabsorbable Staple Line ReinforcementOXC · Special | 08/17/2018SE |
| K173333 | GORE ENFORM BiomaterialOXF · Traditional | 04/05/2018SE |
| K163576 | GORE SYNECOR Preperitoneal BiomaterialFTL · Traditional | 05/11/2017SE |
| K170740 | GORE VIABIL Short Wire Biliary EndoprosthesisFGE · Traditional | 05/08/2017SESU |
| K163217 | GORE BIO-A Tissue ReinforcementOXF · Traditional | 02/10/2017SE |
Questions and answers
When was GORE BIO-A Tissue Reinforcement cleared by the FDA?
GORE BIO-A Tissue Reinforcement (K191773) received a 510(k) decision of Substantially Equivalent on July 31, 2019, 29 days after the submission was received.
What is the product code of K191773?
The FDA product code is OWT – Mesh, Surgical, Absorbable, Abdominal Hernia, a Class II (moderate risk) device regulated under 21 CFR 878.3300.