Gynesonics, Inc. · Class II · Cleared Aug 15, 2018
| K-number | K173703 |
| Device name | Sonata Sonography-Guided Transcervical Fibroid Ablation System |
| Applicant | Gynesonics, Inc. |
| Product code | KNF |
| Device class | Class II |
| Decision date | Aug 15, 2018 |
| Decision | Substantially Equivalent |
| Regulation | 884.4160 |
AI extraction for this record is queued and will appear within 24 hours. View full FDA record →
View the full FDA submission: accessdata.fda.gov