DeviceClearance

Sonata Transcervical Fibroid Ablation System 2.2 (SONATA2-220)— 510(k) K233848

Substantially Equivalent

Gynesonics, Inc.

FDA 510(k) clearance K233848 for Sonata Transcervical Fibroid Ablation System 2.2 (SONATA2-220), Substantially Equivalent on 2023-12-21. Applicant: Gynesonics, Inc..

Clearance details

Applicant
Gynesonics, Inc.
Product code
Code KNF
Advisory panel
Obstetrics/Gynecology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Redwood City, CA, US
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