K183385 is an FDA 510(k) clearance for the NanoKnife System, a Low Energy Direct Current Thermal Ablation System (Class II — Special Controls, product code OAB), submitted by Angiodynamics (Marlborough, US). The FDA issued a Cleared decision on June 18, 2019, 194 days after receiving the submission on December 6, 2018. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4400.
| 510(k) Number | K183385 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | December 06, 2018 |
| Decision Date | June 18, 2019 |
| Days to Decision | 194 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | OAB — Low Energy Direct Current Thermal Ablation System |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 878.4400 |
| Definition | Ablation Of Soft Tissue |