FDA 510(k) clearance · back to tracker

Sonata Transcervical Fibroid Ablation System 2.2

Gynesonics, Inc. cleared K211535 on 2021-06-17, decision: substantially equivalent

K-number

K211535

Sponsor

Gynesonics, Inc.

Device

Sonata Transcervical Fibroid Ablation System 2.2

Class

Class II

Decision

Substantially Equivalent

Decision date

2021-06-17

Product code

KNF

Advisory committee

Obstetrics/Gynecology

Medical specialty

Obstetrics/Gynecology

Regulation number

884.4160

Official FDA record

Open K211535on accessdata.fda.gov →

FDA's authoritative 510(k) summary page. Includes the decision letter, predicate references, and downloadable substantial-equivalence determination.

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Source

Public 510(k) database, U.S. Food and Drug Administration, accessed via openFDA. Page refreshed weekly.