SERI Contour
FDA 510(k) clearance K172545 · decided 2017-09-22
Clearance details
- K-number
- K172545
- Device name
- SERI Contour
- Applicant
- Sofregen Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2017-08-23
- Decision date
- 2017-09-22
- Days to decision
- 30 days
- Clearance type
- Special
- Product code
- OXF
- Device class
- 2
- Regulation number
- 878.3300
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Medford, MA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Restrata Soft Tissue Reinforcement (STR) (K251224) | Acera Surgical, Inc. | 2025-06-20 |
| 3DMatrix DynaFlex (DynaFlex) (K243302) | Printbio, Inc. | 2025-05-21 |
| 3DMatrix Surgical Mesh (K232602) | Printbio, Inc. | 2024-05-23 |
| GORE® ENFORM Biomaterial (K222919) | W. L. Gore and Associates, Inc. | 2022-12-19 |
| GORE ENFORM Biomaterial (K173333) | W. L. Gore & Associates, Inc. | 2018-04-05 |
| GORE BIO-A Tissue Reinforcement (K163217) | W. L. Gore & Associates, Inc. | 2017-02-10 |
| SERI SURGICAL SCAFFOLD (K123128) | Allergan | 2013-04-25 |
Recalls involving this device
No recalls on record reference this clearance.