K102329 is an FDA 510(k) clearance for the NANOKNIFE SYSTEM. This device is classified as a Low Energy Direct Current Thermal Ablation System (Class II - Special Controls, product code OAB).
Submitted by AngioDynamics, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on October 24, 2011, 433 days after receiving the submission on August 17, 2010.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4400. Ablation Of Soft Tissue.
| 510(k) Number | K102329 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 17, 2010 |
| Decision Date | October 24, 2011 |
| Days to Decision | 433 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 |