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FDA 510(k)

Sonata Transcervical Fibroid Ablation System 2.2 (SONATA2-220)

K-Number: K233848 · 2023-12-21

ApplicantGynesonics, Inc.
Decision Date2023-12-21
Product CodeKNF
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Sonata Transcervical Fibroid Ablation System 2.2 (SONATA2-220) is a medical device manufactured by Gynesonics, Inc.. It received FDA 510(k) clearance on 2023-12-21 under approval number K233848. The device is classified under product code KNF. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Sonata Transcervical Fibroid Ablation System 2.2 (SONATA2-220)?

Sonata Transcervical Fibroid Ablation System 2.2 (SONATA2-220) is a medical device that received FDA 510(k) clearance on 2023-12-21. It is manufactured by Gynesonics, Inc.. The 510(k) number is K233848.

When was Sonata Transcervical Fibroid Ablation System 2.2 (SONATA2-220) approved by the FDA?

Sonata Transcervical Fibroid Ablation System 2.2 (SONATA2-220) received FDA 510(k) clearance on 2023-12-21, under approval number K233848.

What company makes Sonata Transcervical Fibroid Ablation System 2.2 (SONATA2-220)?

Sonata Transcervical Fibroid Ablation System 2.2 (SONATA2-220) is manufactured by Gynesonics, Inc..

What is the FDA product code for Sonata Transcervical Fibroid Ablation System 2.2 (SONATA2-220)?

The FDA product code for Sonata Transcervical Fibroid Ablation System 2.2 (SONATA2-220) is KNF.

Related Clinical Trials

NCT07137455 EDEN Intracardiac Electrogram Recording and Classifying System ENROLLING_BY_INVITATION NCT06762717 FARAPULSE™ Pulsed Field Ablation System RECRUITING NCT04345003 MR Elastography Parameters Impact on MR-HIFU Efficacy in Uterine Fibroids COMPLETED NCT06170606 POLARx Post Approval Study (POLARx PAS) ACTIVE_NOT_RECRUITING NCT06510556 Feasibility Study of the FARAFLEX Mapping and PFA System RECRUITING NCT06735534 Repeat Ablation of Persistent Atrial Fibrillation, Including Mitral Isthmus Catheter Ablation, With the FARAPULSE Pulsed Field Ablation System RECRUITING

Related PubMed Literature

PMID: 36632328 Integrating real-world data to assess cardiac ablation device outcomes in a multicenter study using the OMOP common data model for regulatory decisions: implementation and evaluation. JAMIA open (2023)

Other Devices by Gynesonics, Inc.

K173703Sonata Sonography-Guided Transcervical Fibroid Ablation System K193516Sonata® Sonography-Guided Transcervical Fibroid Ablation System 2.1 K211535Sonata Transcervical Fibroid Ablation System 2.2 K222304Sonata Transcervical Fibroid Ablation System 2.2 K240503Sonata Transcervical Fibroid Ablation System 2.2 K250705Sonata Transcervical Fibroid Ablation System 2.2

View all 7 devices →

Related Devices (Code: KNF)

K173703Sonata Sonography-Guided Transcervical Fibroid Ablation SystemGynesonics, Inc. K193516Sonata® Sonography-Guided Transcervical Fibroid Ablation System 2.1Gynesonics, Inc. K211535Sonata Transcervical Fibroid Ablation System 2.2Gynesonics, Inc. K222304Sonata Transcervical Fibroid Ablation System 2.2Gynesonics, Inc. K240503Sonata Transcervical Fibroid Ablation System 2.2Gynesonics, Inc. K250705Sonata Transcervical Fibroid Ablation System 2.2Gynesonics, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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