The following data is part of a premarket notification filed by Angiodynamics, Inc. with the FDA for Nanoknife System.
| Device ID | K102329 |
| 510k Number | K102329 |
| Device Name: | NANOKNIFE SYSTEM |
| Classification | Low Energy Direct Current Thermal Ablation System |
| Applicant | ANGIODYNAMICS, INC. 155-A MOFFETT PARK DRIVE SUITE 210 Sunnyvale, CA 94089 |
| Contact | Kit Cariquitan |
| Correspondent | Kit Cariquitan ANGIODYNAMICS, INC. 155-A MOFFETT PARK DRIVE SUITE 210 Sunnyvale, CA 94089 |
| Product Code | OAB |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-08-17 |
| Decision Date | 2011-10-24 |
| Summary: | summary |