K-number	K233848
Device name	Sonata Transcervical Fibroid Ablation System 2.2 (SONATA2-220)
Applicant	Gynesonics, Inc.
Product code	KNF
Device class	Class II
Decision date	Dec 21, 2023
Decision	Substantially Equivalent
Regulation	884.4160

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View the full FDA submission: accessdata.fda.gov

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Sonata Transcervical Fibroid Ablation System 2.2 (SONATA2-220)

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