Mesh, Surgical, Absorbable, Abdominal Hernia
The Mesh, Surgical, Absorbable, Abdominal Hernia is an absorbable surgical mesh implant used for reinforcement of soft tissue where weakness exists during hernia repair of the abdominal wall. It is classified as Class 2 (FDA Class 2), requiring 510(k) premarket clearance. The product code is OWT, with regulation number 878.3300 under the General, Plastic Surgery medical specialty, and it carries an implant flag.
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Basic Information
- Product Code
- OWT
- Device Class
- FDA class 2
- Regulation Number
- 878.3300
- Medical Specialty
- General, Plastic Surgery
- Review Panel
- SU
- Submission Type
- 1
Device Characteristics
Definition
For reinforcement of soft tissue where weakness exists during hernia repair.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 11 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K243241 | Phasix ST Umbilical Hernia Patch | Feb 19, 2025 | Substantially Equivalent | Davol, Inc., A Subsidiary of C.R. Bard, Inc. |
| K233661 | Transorb Self-Gripping Resorbable Mesh | Feb 13, 2024 | Substantially Equivalent | Sofradim Production |
| K191749 | TIGR Matrix Surgical Mesh, TIGR Surgical Mesh | Mar 26, 2020 | Substantially Equivalent | Novus Scientific AB |
| K191773 | GORE BIO-A Tissue Reinforcement | Jul 31, 2019 | Substantially Equivalent | W. L. Gore & Associates, Inc. |
| K190185 | Phasix ST Mesh with Open Positioning System | Jun 12, 2019 | Substantially Equivalent | C.R. Bard, Inc. |
| K173143 | Phasix ST Mesh | Apr 25, 2018 | Substantially Equivalent | C.R. Bard, Inc. |
| K163005 | TIGR Matrix Surgical Mesh | Jul 27, 2017 | Substantially Equivalent | Novus Scientific AB |
| K143380 | Phasix ST Mesh | Jun 05, 2015 | Substantially Equivalent | C.R. Bard, Inc. |
| K120728 | PHASIX PLUG AND PATCH | Oct 22, 2012 | Substantially Equivalent | C.R. Bard, Inc. |
| K101287 | TEPHAFLEX COMPOSITE MESH | Aug 30, 2010 | Substantially Equivalent | Tepha, Inc. |
| K033671 | GORE BIOABSORBABLE MESH | Dec 31, 2003 | Substantially Equivalent | W. L. Gore & Associates, Inc. |
FEI Numbers
This FDA classification entry is associated with 12 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 12 registration numbers. Click on an entry to view related FDA registrations.