K191961 is an FDA 510(k) clearance for the OrthoGold. This device is classified as a Extracorporeal Shock Wave Device For Treatment Of Diabetic Foot Ulcers (Class II - Special Controls, product code PZL).
Submitted by Tissue Regeneration Technologies (Woodstock, US). The FDA issued a Cleared decision on November 26, 2019, 126 days after receiving the submission on July 23, 2019.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4685. Treatment Of Diabetic Foot Ulcers.
| 510(k) Number | K191961 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 23, 2019 |
| Decision Date | November 26, 2019 |
| Days to Decision | 126 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | PZL - Extracorporeal Shock Wave Device For Treatment Of Diabetic Foot Ulcers |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4685 |
| Definition | Treatment Of Diabetic Foot Ulcers |