gynesonics.comSonata Transcervical Fibroid Ablation System 2.2
Gynesonics, Inc.
GYNESONICS, INC.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3005875675 | 3005875675 | GYNESONICS, INC. | 1 | N | 2026-01-01 | 200 Cardinal Way #250 REDWOOD CITY CA US 94063 |
| 3005875675 | 3005875675 | GYNESONICS, INC. | 1 | N | 2020-04-25 | 600 Chesapeake Drive REDWOOD CITY CA US 94063 |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 10817929020241 | Sonata® Intrauterine Ultrasound Probe - Ultrasound-guided intrauterine electrosurgical diathermy system intrauterine ultrasound transducer, Sterile | 650-216-3860 | customersupport@gynesonics.com |
| 10817929020340 | Sonata System Software - SW-002 | 650-216-3860 | customersupport@gynesonics.com |
| 10817929020357 | Sonata® System Software - Ultrasound-guided radio-frequency ablation system software | 650-216-3860 | customersupport@gynesonics.com |
| 10817929020364 | Sonata® Dispersive Electrode - Electrosurgical return electrode, single-use | 650-216-3860 | UScustomerservice@gynesonics.com |
| 10817929020463 | Sonata® IUUS Probe Connector Protector - Accessory to the Sonata® Intrauterine Ultrasound (IUUS) Probe. Provides water-tight cover for the electrical connector of the IUUS Probe during liquid reprocessing procedures. | 650-216-3860 | UScustomerservice@gynesonics.com |
| 30817929020177 | Sonata® RFA Handpiece Cable, Reusable - Electrical-only medical device connection cable, reusable | 6502163860 | UScustomerservice@gynesonics.com |
| 30817929020450 | Sonata® IUUS Probe Leak Tester - Invasive medical device leak tester, mechanical. | 650-216-3860 | customersupport@gynesonics.com |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 342045 | 1961946932 | K250705 | Sonata Transcervical Fibroid Ablation System 2.2 | KNF | 2025-04-02 |
| 342045 | 1318492505 | K240503 | Sonata Transcervical Fibroid Ablation System 2.2 | KNF | 2024-07-17 |
| 342045 | 1061407327 | K222304 | Sonata Transcervical Fibroid Ablation System 2.2 | KNF | 2022-11-08 |
| 342045 | 1181664826 | K211535 | Sonata Transcervical Fibroid Ablation System 2.2 | KNF | 2021-06-17 |
| 66655 | 2044431334 | K173703 | Sonata Sonography-Guided Transcervical Fibroid Ablation System | KNF | 2018-08-15 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| KNF | 5 | 2025-04-02 |
PMN#
Sonata Transcervical Fibroid Ablation System 2.2 (SONATA2-220)
Gynesonics, Inc.
Sonata Transcervical Fibroid Ablation System 2.2
Gynesonics, Inc.
Sonata Transcervical Fibroid Ablation System 2.2
Gynesonics, Inc.
Sonata® Sonography-Guided Transcervical Fibroid Ablation System 2.1
Gynesonics, Inc
Sonata Sonography-Guided Transcervical Fibroid Ablation System
Gynesonics, Inc.
GYNESONICS EC6 TRANSDUCER
GYNESONICS, INC.
GUDID#
Sonata® System Software - Ultrasound-guided radio-frequency ablation system software
2020-02-21
Sonata System Software - SW-002
2020-10-07
Sonata Dispersive Electrode - DE-002
2026-08-25
Sonata® Intrauterine Ultrasound Probe - Ultrasound-guided intrauterine electrosurgical diathermy system intrauterine ultrasound transducer, Sterile
2019-05-10
Sonata® Dispersive Electrode - Electrosurgical return electrode, single-use
2021-07-07
Sonata® RFA Handpiece Cable, Reusable - Electrical-only medical device connection cable, reusable
2021-07-07
Sonata® IUUS Probe Leak Tester - Invasive medical device leak tester, mechanical.
2023-06-20
Sonata® IUUS Probe Connector Protector - Accessory to the Sonata® Intrauterine Ultrasound (IUUS) Probe. Provides water-tight cover for the electrical connector of the IUUS Probe during liquid reprocessing procedures.
2022-12-12
Sonata® IUUS probe Leak Tester Kit - Invasive medical device leak tester, mechanical.
2023-06-20
Sonata® Radiofrequency Ablation Handpiece - Ultrasound-guided intrauterine electrosurgical handpiece/ electrode
2021-07-07
Sonata® Intrauterine Ultrasound Probe Return Kit - RTN-001
2020-10-07
Sonata® Procedure Kit - Convenience Kit containing one model RFA-002 sterile single-use ultrasound-guided intrauterine electrosurgical handpiece / electrode, two model DE-001 single-use electrosurgical return electrodes, and one model ACCY-007 sterile single-use electrosurgical handpiece cable.
2020-10-07
Sonata® Case Kit - Convenience Kit containing one model RFA-001 sterile single-use ultrasound-guided intrauterine electrosurgical handpiece / electrode, and two model DE-001 single-use electrosurgical return electrodes
2019-05-10
Sonata® IUUS Probe Sterile Shipper Kit - Sterilization packaging, single use
2019-05-10
Sonata® IUUS Probe Soaking Cylinder - General laboratory container, reusable
2019-05-10
Sonata® System Cart - Electromechanical device transport trolley
2019-05-10
Sonata® SMART Tablet - Ultrasound -guided intrauterine electrosurgical system ultrasound control unit
2019-05-10
Sonata® System Radiofrequency Generator - Ultrasound-guided intrauterine electrosurgical system generator
2019-05-10
Sonata® Sonography-Guided Transcervical Fibroid Ablation System - Ultrasound-guided intrauterine electrosurgical system. This system includes a cart, ultrasound console, RF generator, and component kit.
2019-05-10
Sonata® Intrauterine Ultrasound Probe - Ultrasound-guided intrauterine electrosurgical diathermy system intrauterine ultrasound transducer
2019-05-10
Sonata® IUUS Probe Leak Tester - Invasive medical device leak tester, mechanical.
2023-06-20
Sonata® Dispersive Electrode - Electrosurgical return electrode, single-use
2021-07-07
Sonata® RFA Handpiece Cable, Reusable - Electrical-only medical device connection cable, reusable
2021-07-07
Sonata® Intrauterine Ultrasound Probe - Ultrasound-guided intrauterine electrosurgical diathermy system intrauterine ultrasound transducer, Sterile
2019-05-10