FDA 510(k) clearance · back to tracker

Sonata® Sonography-Guided Transcervical Fibroid Ablation System 2.1

Gynesonics, Inc. cleared K193516 on 2020-05-04, decision: substantially equivalent

K-number

K193516

Sponsor

Gynesonics, Inc.

Device

Sonata® Sonography-Guided Transcervical Fibroid Ablation System 2.1

Class

Class II

Decision

Substantially Equivalent

Decision date

2020-05-04

Product code

KNF

Advisory committee

Obstetrics/Gynecology

Medical specialty

Obstetrics/Gynecology

Regulation number

884.4160

Official FDA record

Open K193516on accessdata.fda.gov →

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

openFDA JSON

Raw record →

Machine-readable JSON. Useful for cross-referencing classification, product code, and advisory committee fields.

Use this as a predicate

Drop K193516 into Compass and start a substantial-equivalence draft.

Compass pulls the predicate's intended use, technological characteristics, and performance data, maps them against your device, and produces a draft SE table aligned to FDA's 510(k) program guidance.

Try the sandbox

Source

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