510(k) K163217
- Device
- GORE BIO-A Tissue Reinforcement
- Applicant
- W. L. GORE & ASSOCIATES, INC.
- 510(k) number
- K163217
- Product code
- OXF
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2017-02-10
- Date received
- 2016-11-16
- Regulation
- 878.3300
- Classification name
- Mesh, Surgical, Absorbable, Plastic And Reconstructive Surgery
- Medical specialty
- General & Plastic Surgery
- Review panel
- General & Plastic Surgery
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Barbara L Smith
- Address
- 301 Airport Rd. P.O. Box 1408 Elkton MD US 21922 21922
FDA Registration Numbers#
- 3003910212
- 3002924436
- 3004681519
- 3012429393
- 1319639
- 3002719998
- 3006017180
Source Documents#
Other 510(k) Records For Product Code OXF #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K251224 | Restrata Soft Tissue Reinforcement (STR) | Acera Surgical, Inc. | 2025-06-20 |
| K243302 | 3DMatrix DynaFlex (DynaFlex) | Printbio, Inc. | 2025-05-21 |
| K232602 | 3DMatrix Surgical Mesh | Printbio, Inc. | 2024-05-23 |
| K222919 | GORE® ENFORM Biomaterial | W. L. Gore and Associates, Inc. | 2022-12-19 |
| K173333 | GORE ENFORM Biomaterial | W. L. Gore & Associates, Inc. | 2018-04-05 |
| K172545 | SERI Contour | Sofregen Medical, Inc. | 2017-09-22 |
| K123128 | SERI SURGICAL SCAFFOLD | Allergan | 2013-04-25 |
Legacy Summary#
summary
FDA Review#
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