FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
GalaFORM 3D
K Number: K162922
·
Decision Feb 23, 2017
Classifications
1
FEI Numbers
12
Registration Numbers
12
Same Product Code
12
Applicant Total
18
Review Days
128
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- GalaFORM 3D
- K Number
- K162922
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.3300
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Tepha, Inc.
- Date Received
- October 18, 2016
- Decision Date
- February 23, 2017
- Product Code
- OOD
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| OOD | Surgical Film | FDA class 2 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (OOD), ordered by most recent decision date.
GalaFLEX LITE Scaffold
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SurgiLattice scaffold
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Phasix Mesh
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
GalaSHAPE 3D
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Phasix Mesh
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
GALAFLEX MESH
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Other Clearances by Tepha, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K233999 | GalaFLEX LITE Scaffold | Apr 9, 2024 | Substantially Equivalent |
| K202425 | SurgiLattice scaffold | Aug 19, 2021 | Substantially Equivalent |
| K211307 | GalaSTITCH Absorbable Monofilament Suture | May 27, 2021 | Substantially Equivalent |
| K161092 | GalaSHAPE 3D | Aug 23, 2016 | Substantially Equivalent |
| K140533 | GALAFLEX MESH | May 21, 2014 | Substantially Equivalent |
| K132348 | TEPHAFLEX BRAIDED SUTURE | Sep 5, 2013 | Substantially Equivalent |
| K130326 | TEPHAFLEX MELTBLOWN CONSTRUCT | May 7, 2013 | Substantially Equivalent |
| K113721 | TEPHAFLEX LIGHT MESH | Feb 15, 2012 | Substantially Equivalent |
| K113723 | TEPHAFLEX MESH | Feb 15, 2012 | Substantially Equivalent |
| K111946 | TEPHAFLEX MESH | Sep 26, 2011 | Substantially Equivalent |