FDA.reportPublic FDA data

Sonata® System Radiofrequency Generator

Primary DI
10817929020203
Brand
Sonata® System Radiofrequency Generator
Company
Gynesonics, Inc.
Model
RFG2-110
Catalog number
RFG2-110
Device description
Ultrasound-guided intrauterine electrosurgical system generator
Published
2019-05-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
IYOSystem, Imaging, Pulsed Echo, Ultrasonic
KNFCoagulator-Cutter, Endoscopic, Unipolar (And Accessories)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IYOSystem, Imaging, Pulsed Echo, UltrasonicRadiology2
KNFCoagulator-Cutter, Endoscopic, Unipolar (And Accessories)Obstetrics/Gynecology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K173703000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K173703000Sonata Sonography-Guided Transcervical Fibroid Ablation SystemGynesonics, Inc.2018-08-15KNF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10817929020203PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1081792902020310817929020203

GMDN Terms#

Term, Definition table
TermDefinition
Ultrasound-guided intrauterine electrosurgical system generatorA mains electricity (AC-powered) component of an ultrasound-guided intrauterine electrosurgical system designed to generate a high frequency electrical current in selected radio-frequency (RF) bands between two electrodes to produce heat directly within soft-tissue cells for intrauterine ablation of uterine fibroids; the RF energy is delivered to the site of intervention via a dedicated handpiece and electrode. It also typically provides continuous tissue temperature monitoring, and impedance and power monitoring with tissue overheating safety systems. It is configured with dedicated application software and includes user interface/controls and inputs for other system components.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature-20 Degrees Celsius45 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
650-216-3860customersupport@gynesonics.com

Regulatory Flags#

DUNS number
618493741
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10817929020241Sonata® Intrauterine Ultrasound ProbeIUSP-002SIUSP-002S2019-05-10
10817929020364Sonata® Dispersive ElectrodeDE-001DE-0012021-07-07
30817929020177Sonata® RFA Handpiece Cable, ReusableACCY-008ACCY-0082021-07-07
30817929020450Sonata® IUUS Probe Leak TesterACCY-017ACCY-0172023-06-20
10817929020463Sonata® IUUS Probe Connector Protector ACCY-018ACCY-0182022-12-12
10817929020449Sonata® IUUS probe Leak Tester KitACCY-016ACCY-0162023-06-20
10817929020371Sonata® Radiofrequency Ablation HandpieceRFA-002RFA-0022021-07-07
10817929020357Sonata® System SoftwareSW-001SW-0012020-02-21
10817929020036Sonata® Intrauterine Ultrasound Probe Return KitRTN-001RTN-0012020-10-07
10817929020166Sonata® Procedure Kit PROKIT-001PROKIT-0012020-10-07
10817929020340Sonata System SoftwareSW-002SW-0022020-10-07
10817929020005Sonata® Case Kit CSKIT-001CSKIT-0012019-05-10
10817929020135Sonata® IUUS Probe Sterile Shipper KitSHPR-001SHPR-0012019-05-10
10817929020142Sonata® IUUS Probe Soaking CylinderCYL-001CYL-0012019-05-10
10817929020180Sonata® System Cart ACCY-002ACCY-0022019-05-10
10817929020197Sonata® SMART TabletUSCON-2200USCON-22002019-05-10
10817929020326Sonata® Sonography-Guided Transcervical Fibroid Ablation System SONATA2-110SONATA2-1102019-05-10
30817929020092Sonata® Intrauterine Ultrasound ProbeIUSP-002IUSP-0022019-05-10
10817929020456Sonata® IUUS Probe Leak TesterACCY-017ACCY-0172023-06-20
30817929020368Sonata® Dispersive ElectrodeDE-001DE-0012021-07-07

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