FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
OrthoGold
K Number: K191961
·
Decision Nov 26, 2019
Classifications
1
FEI Numbers
16
Registration Numbers
16
Same Product Code
7
Applicant Total
2
Review Days
126
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
- OrthoGold
- K Number
- K191961
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4685
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Tissue Regeneration Technologies
- Date Received
- July 23, 2019
- Decision Date
- November 26, 2019
- Product Code
- PZL
- 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 |
|---|---|---|---|
| PZL | Extracorporeal Shock Wave Device For Treatment Of Diabetic Foot Ulcers | FDA class 2 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (PZL), ordered by most recent decision date.
DOLORCLAST Focused Shock Waves
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
CS-Pro MED
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
OW100S
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
OW100S
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Storz Medical Duolith SD1 T-Top & Tower System with C-Actor Sepia Handpiece
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
OrthoGold 100
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Other Clearances by Tissue Regeneration Technologies
| K Number | Device Name | ||
|---|---|---|---|
| K182682 | OrthoGold 100 | Dec 21, 2018 | Substantially Equivalent |