GORE ENFORM Biomaterial
FDA 510(k) K173333 · W. L. Gore & Associates, Inc.
510(k) numberK173333
Submission
- Device name
- GORE ENFORM Biomaterial
- Applicant
- W. L. Gore & Associates, Inc.
Flagstaff, AZ, US - Received
- October 23, 2017
- Decision date
- April 5, 2018
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OXF – Mesh, Surgical, Absorbable, Plastic And Reconstructive Surgery
- 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 in plastic and reconstructive surgery.
Other 510(k)s with product code OXF
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K251224 | Restrata Soft Tissue Reinforcement (STR)OXF · Traditional | Acera Surgical, Inc. | 06/20/2025SE |
| K243302 | 3DMatrix DynaFlex (DynaFlex)OXF · Traditional | Printbio, Inc. | 05/21/2025SE |
| K232602 | 3DMatrix Surgical MeshOXF · Traditional | Printbio, Inc. | 05/23/2024SE |
| K222919 | GORE® ENFORM BiomaterialOXF · Traditional | W. L. Gore and Associates, Inc. | 12/19/2022SE |
| K172545 | SERI ContourOXF · Special | Sofregen Medical, Inc. | 09/22/2017SE |
| K163217 | GORE BIO-A Tissue ReinforcementOXF · Traditional | W. L. Gore & Associates, Inc. | 02/10/2017SE |
| K123128 | Seri Surgical ScaffoldOXF · Traditional | Allergan | 04/25/2013SE |
More from Allergan
| 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 |
| K191773 | GORE BIO-A Tissue ReinforcementOWT · Special | 07/31/2019SE |
| K181940 | GORE SEAMGUARD Bioabsorbable Staple Line ReinforcementOXC · Special | 08/17/2018SE |
| 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 ENFORM Biomaterial cleared by the FDA?
GORE ENFORM Biomaterial (K173333) received a 510(k) decision of Substantially Equivalent on April 5, 2018, 164 days after the submission was received.
What is the product code of K173333?
The FDA product code is OXF – Mesh, Surgical, Absorbable, Plastic And Reconstructive Surgery, a Class II (moderate risk) device regulated under 21 CFR 878.3300.