GalaSHAPE 3D
FDA 510(k) clearance K161092 · decided 2016-08-23
Clearance details
- K-number
- K161092
- Device name
- GalaSHAPE 3D
- Applicant
- Tepha, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2016-04-18
- Decision date
- 2016-08-23
- Days to decision
- 127 days
- Clearance type
- Traditional
- Product code
- OOD
- Device class
- 2
- Regulation number
- 878.3300
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Lexington, 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 |
|---|---|---|
| GalaFLEX LITE Scaffold (K233999) | Tepha, Inc. | 2024-04-09 |
| SurgiLattice scaffold (K202425) | Tepha, Inc. | 2021-08-19 |
| GalaFORM 3D (K162922) | Tepha, Inc. | 2017-02-23 |
| Phasix Mesh (K161424) | C.R. Bard, Inc. | 2016-09-29 |
| Phasix Mesh (K142818) | C. R. Bard | 2015-03-31 |
| GALAFLEX MESH (K140533) | Tepha, Inc. | 2014-05-21 |
| TEPHAFLEX MELTBLOWN CONSTRUCT (K130326) | Tepha, Inc. | 2013-05-07 |
| TEPHAFLEX LIGHT MESH (K113721) | Tepha, Inc. | 2012-02-15 |
| TEPHAFLEX MESH (K113723) | Tepha, Inc. | 2012-02-15 |
| TEPHAFLEX MESH (K111946) | Tepha, Inc. | 2011-09-26 |
| TEPHAFLEX SURGICAL FILM (K091633) | Tepha, Inc. | 2009-08-07 |
| TEPHAFLEX SURGICAL MESH (K070894) | Tepha, Inc. | 2007-04-13 |
Recalls involving this device
No recalls on record reference this clearance.