The following data is part of a premarket notification filed by Angiodynamics, Inc. with the FDA for Nanoknife System.
| Device ID | K150089 |
| 510k Number | K150089 |
| Device Name: | NanoKnife System |
| Classification | Low Energy Direct Current Thermal Ablation System |
| Applicant | ANGIODYNAMICS, INC. 26 FOREST STREET Marlborough, MA 01752 |
| Contact | Suzanne Goodman |
| Correspondent | Suzanne Goodman ANGIODYNAMICS, INC. 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 | 2015-01-16 |
| Decision Date | 2015-06-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H787204003015 | K150089 | 000 |
| H787203001010 | K150089 | 000 |
| H78720300101US0 | K150089 | 000 |
| H787204001015 | K150089 | 000 |
| H787204001025 | K150089 | 000 |
| H787204001030 | K150089 | 000 |
| H787204001035 | K150089 | 000 |
| H787204001040 | K150089 | 000 |
| H787204001045 | K150089 | 000 |
| H787204001050 | K150089 | 000 |
| H787204001055 | K150089 | 000 |
| H787204001060 | K150089 | 000 |
| H787204001065 | K150089 | 000 |
| H787204001070 | K150089 | 000 |
| H787204001080 | K150089 | 000 |
| 15051684029643 | K150089 | 000 |