Sonata Transcervical Fibroid Ablation System 2.2— 510(k) K240503
Substantially EquivalentGynesonics, Inc.
FDA 510(k) clearance K240503 for Sonata Transcervical Fibroid Ablation System 2.2, Substantially Equivalent on 2024-07-17. Applicant: Gynesonics, Inc.. Device class: 2.
Clearance details
- Applicant
- Gynesonics, Inc.
- Product code
- Product code KNF
- Device class
- Class 2
- Regulation
- 21 CFR 884.4160
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Redwood City, CA, US
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