GalaFORM 3D
FDA 510(k) K162922 · Tepha, Inc.
510(k) numberK162922
Submission
- Device name
- GalaFORM 3D
- Applicant
- Tepha, Inc.
Lexington, MA, US - Received
- October 18, 2016
- Decision date
- February 23, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OOD – Surgical Film
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.3300
- Specialty
- General, Plastic Surgery
- Implant
- Yes
- Life-sustaining
- Yes
To be implanted to reinforce soft tissue or bone where weakness exists. Intended to be used wherever temporary wound support is required, to reinforce soft tissues where weakness exists in the urological, gynecological, or gastrointestinal anatomy, or for the repair of hernia or other fascial defects that require the addition of a reinforcing or bridging material to obtain the desired surgical…
Other 510(k)s with product code OOD
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K233999 | GalaFLEX LITE ScaffoldOOD · Traditional | Tepha, Inc. | 04/09/2024SE |
| K202425 | SurgiLattice scaffoldOOD · Traditional | Tepha, Inc. | 08/19/2021SE |
| K161424 | Phasix MeshOOD · Traditional | C.R. Bard, Inc. | 09/29/2016SE |
| K161092 | GalaSHAPE 3DOOD · Traditional | Tepha, Inc. | 08/23/2016SE |
| K142818 | Phasix MeshOOD · Traditional | C. R. Bard | 03/31/2015SE |
| K140533 | Galaflex MeshOOD · Traditional | Tepha, Inc. | 05/21/2014SE |
| K130326 | Tephaflex Meltblown ConstructOOD · Traditional | Tepha, Inc. | 05/07/2013SE |
| K113723 | Tephaflex MeshOOD · Traditional | Tepha, Inc. | 02/15/2012SE |
| K113721 | Tephaflex Light MeshOOD · Traditional | Tepha, Inc. | 02/15/2012SE |
| K111946 | Tephaflex MeshOOD · Traditional | Tepha, Inc. | 09/26/2011SE |
More from Tepha, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K233999 | GalaFLEX LITE ScaffoldOOD · Traditional | 04/09/2024SE |
| K202425 | SurgiLattice scaffoldOOD · Traditional | 08/19/2021SE |
| K211307 | GalaSTITCH Absorbable Monofilament SutureNWJ · Special | 05/27/2021SE |
| K161092 | GalaSHAPE 3DOOD · Traditional | 08/23/2016SE |
| K140533 | Galaflex MeshOOD · Traditional | 05/21/2014SE |
| K132348 | Tephaflex Braided SutureNWJ · Traditional | 09/05/2013SE |
| K130326 | Tephaflex Meltblown ConstructOOD · Traditional | 05/07/2013SE |
| K113723 | Tephaflex MeshOOD · Traditional | 02/15/2012SE |
| K113721 | Tephaflex Light MeshOOD · Traditional | 02/15/2012SE |
| K111946 | Tephaflex MeshOOD · Traditional | 09/26/2011SE |
Questions and answers
When was GalaFORM 3D cleared by the FDA?
GalaFORM 3D (K162922) received a 510(k) decision of Substantially Equivalent on February 23, 2017, 128 days after the submission was received.
What is the product code of K162922?
The FDA product code is OOD – Surgical Film, a Class II (moderate risk) device regulated under 21 CFR 878.3300.