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Gynesonics, Inc.

FDA 510(k) & PMA Approved Devices — 7 products

Total Devices7
Categories1
Latest Approval2025-04-02
TypeNumberDevice NameCodeDate
510(k) K250705 Sonata Transcervical Fibroid Ablation System 2.2 KNF 2025-04-02 View
510(k) K240503 Sonata Transcervical Fibroid Ablation System 2.2 KNF 2024-07-17 View
510(k) K233848 Sonata Transcervical Fibroid Ablation System 2.2 (SONATA2-220) KNF 2023-12-21 View
510(k) K222304 Sonata Transcervical Fibroid Ablation System 2.2 KNF 2022-11-08 View
510(k) K211535 Sonata Transcervical Fibroid Ablation System 2.2 KNF 2021-06-17 View
510(k) K193516 Sonata® Sonography-Guided Transcervical Fibroid Ablation System 2.1 KNF 2020-05-04 View
510(k) K173703 Sonata Sonography-Guided Transcervical Fibroid Ablation System KNF 2018-08-15 View