The following data is part of a premarket notification filed by Angiodynamics with the FDA for Nanoknife System.
| Device ID | K183385 |
| 510k Number | K183385 |
| Device Name: | NanoKnife System |
| Classification | Low Energy Direct Current Thermal Ablation System |
| Applicant | Angiodynamics 26 Forest Street Marlborough, MA 01752 |
| Contact | Troy Roberts |
| Correspondent | Troy Roberts Angiodynamics 26 Forest Street Marlborough, MA 01752 |
| Product Code | OAB |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-12-06 |
| Decision Date | 2019-06-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H787204001100 | K183385 | 000 |
| H787204001090 | K183385 | 000 |
| H78720300301US0 | K183385 | 000 |