Sonata Transcervical Fibroid Ablation System 2.2— 510(k) K250705
Substantially EquivalentGynesonics, Inc.
FDA 510(k) clearance K250705 for Sonata Transcervical Fibroid Ablation System 2.2, Substantially Equivalent on 2025-04-02. Applicant: Gynesonics, Inc.. Device class: 2.
Clearance details
- Applicant
- Gynesonics, Inc.
- Product code
- Code KNF
- Device class
- Class 2
- Regulation
- 21 CFR 884.4160
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Redwood City, CA, US
Recent devices under product code KNF
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- K222304 — Sonata Transcervical Fibroid Ablation System 2.2
- K211535 — Sonata Transcervical Fibroid Ablation System 2.2
- K193516 — Sonata® Sonography-Guided Transcervical Fibroid Ablation System 2.1
More clearances from Gynesonics, Inc.
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