# Gynesonics, Inc.

- Location (FDA's records): Redwood City, CA
- FDA decisions: 8 (2006–2025): 8 510(k) clearances
- Product codes: KNF (7), ITX (1)
- Predicates its devices cite: 11 (7 its own); citations of its devices by later devices: 7 (7 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Teratech Corp.: 3 (https://510kreport.com/company/teratech)
- Halt Medical, Inc.: 1 (https://510kreport.com/company/halt-medical)

## Its most-cited devices
- K240503: Sonata Transcervical Fibroid Ablation System 2.2 (2024), cited by 1
- K173703: Sonata Sonography-Guided Transcervical Fibroid Ablation System (2018), cited by 1
- K193516: Sonata® Sonography-Guided Transcervical Fibroid Ablation System 2.1 (2020), cited by 1
- K211535: Sonata Transcervical Fibroid Ablation System 2.2 (2021), cited by 1
- K061153: Gynesonics EC6 Transducer (2006), cited by 1
- K233848: Sonata Transcervical Fibroid Ablation System 2.2 (SONATA2-220) (2023), cited by 1

## Recent decisions
- K250705: Sonata Transcervical Fibroid Ablation System 2.2 (Apr 2, 2025)
- K240503: Sonata Transcervical Fibroid Ablation System 2.2 (Jul 17, 2024)
- K233848: Sonata Transcervical Fibroid Ablation System 2.2 (SONATA2-220) (Dec 21, 2023)
- K222304: Sonata Transcervical Fibroid Ablation System 2.2 (Nov 8, 2022)
- K211535: Sonata Transcervical Fibroid Ablation System 2.2 (Jun 17, 2021)
- K193516: Sonata® Sonography-Guided Transcervical Fibroid Ablation System 2.1 (May 4, 2020)
- K173703: Sonata Sonography-Guided Transcervical Fibroid Ablation System (Aug 15, 2018)
- K061153: Gynesonics EC6 Transducer (Oct 27, 2006)

Source page: https://510kreport.com/company/gynesonics