The following data is part of a premarket notification filed by Gynesonics, Inc. with the FDA for Sonata Sonography-guided Transcervical Fibroid Ablation System.
| Device ID | K173703 |
| 510k Number | K173703 |
| Device Name: | Sonata Sonography-Guided Transcervical Fibroid Ablation System |
| Classification | Coagulator-cutter, Endoscopic, Unipolar (and Accessories) |
| Applicant | Gynesonics, Inc. 301 Galveston Drive Redwood City, CA 94063 |
| Contact | Diane King |
| Correspondent | Diane King 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-12-04 |
| Decision Date | 2018-08-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30817929020092 | K173703 | 000 |
| 10817929020036 | K173703 | 000 |
| 10817929020005 | K173703 | 000 |
| 10817929020135 | K173703 | 000 |
| 10817929020180 | K173703 | 000 |
| 10817929020197 | K173703 | 000 |
| 10817929020203 | K173703 | 000 |
| 10817929020098 | K173703 | 000 |
| 10817929020326 | K173703 | 000 |
| 10817929020357 | K173703 | 000 |