Skip to content

Sonata System Software SW-002

by Gynesonics, Inc.

Sonata System Software SW-002 is a Class II device made by Gynesonics, Inc., listed in FDA GUDID since 7 Oct 2020 (UDI-DI 10817929020340), registry data as of 23 Oct 2026.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10817929020340 UDI-DI Date7 Oct 2020ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade name
Sonata System Software
Generic name
Ultrasound-guided intrauterine radio-frequency ablation system software
Model / Ref / Catalog
SW-002
Primary DI / UDI-DI
10817929020340
FDA product code
KNF
GMDN term
Ultrasound-guided intrauterine radio-frequency ablation system software
Device class
Class II
Regulation number
884.4160
GUDID distribution status
In Commercial Distribution

Similar devices

Other devices filed under FDA product code KNF (Coagulator-Cutter, Endoscopic, Unipolar (And Accessories)).

Other devices from Gynesonics, Inc.

See all devices from Gynesonics, Inc. →

Properties

  • Prescription use
  • Lot / batch number
Other properties (13, all answered No)