Sonata® System Software

FDA UDI

Class II (US FDA UDI)

by Gynesonics, Inc.

Identity

Trade Name: Sonata® System Software FDA UDI
Generic Name: Ultrasound-guided radio-frequency ablation system software FDA UDI
Device Name: Ultrasound-guided radio-frequency ablation system software FDA UDI
Model / Reference: SW-001 FDA UDI
Description: Ultrasound-guided radio-frequency ablation system software FDA UDI

Identifiers

Catalog Number: SW-001 FDA UDI
Primary DI / UDI-DI: 10817929020357 FDA UDI
510(k) Number: K173703 FDA UDI
FDA Product Code: KNF FDA UDI
ITX FDA UDI
IYO FDA UDI
GMDN Term: Ultrasound-guided radio-frequency ablation system software FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 884.4160 FDA UDI
892.1570 FDA UDI
892.1560 FDA UDI
Commercial Distribution: Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sonata® System Software by Gynesonics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K173703 also covers:

Sonata® System Radiofrequency Generator — Gynesonics, Inc.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Gynesonics, Inc.

Sources (1)

FDA UDI bd557c4f-a8c2-4bf5-8ef1-2b60d3ca7df1 37 fields · synced May 31, 2026