The following data is part of a premarket notification filed by Gynesonics, Inc. with the FDA for Sonata Transcervical Fibroid Ablation System 2.2.
| Device ID | K211535 |
| 510k Number | K211535 |
| Device Name: | Sonata Transcervical Fibroid Ablation System 2.2 |
| Classification | Coagulator-cutter, Endoscopic, Unipolar (and Accessories) |
| Applicant | Gynesonics, Inc. 600 Chesapeake Drive Redwood City, CA 94063 |
| Contact | Christine Ehmann |
| Correspondent | Christine Ehmann Gynesonics, Inc. 600 Chesapeake Drive Redwood City, CA 94063 |
| Product Code | KNF |
| Subsequent Product Code | ITX |
| Subsequent Product Code | IYO |
| CFR Regulation Number | 884.4160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-05-18 |
| Decision Date | 2021-06-17 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10817929020173 | K211535 | 000 |
| 10817929020371 | K211535 | 000 |