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Sonata® Sonography-Guided Transcervical Fibroid Ablation System 2.1

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K193516
510(k) Type
Traditional
Applicant
Gynesonics, Inc
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
5/4/2020
Days to Decision
137 days
Submission Type
Summary

Sonata® Sonography-Guided Transcervical Fibroid Ablation System 2.1

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K193516
510(k) Type
Traditional
Applicant
Gynesonics, Inc
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
5/4/2020
Days to Decision
137 days
Submission Type
Summary