GYNESONICS, INC.

Address:600 Chesapeake Drive,REDWOOD CITY,CA,94063,US

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Coagulator-Cutter, Endoscopic, Unipolar (And Accessories) (KNF) (9) System, Imaging, Pulsed Echo, Ultrasonic (IYO) (5) Transducer, Ultrasonic, Diagnostic (ITX) (5)

Premarket Exempt

No Yes

Clear

Sonata® Case Kit - 10817929020005 Catalog Number : CSKIT-001

Device Description : Convenience Kit containing one model RFA-001 sterile single-use ultrasound-guide Convenience Kit containing one model RFA-001 sterile single-use ultrasound-guided intrauterine electrosurgical handpiece / electrode, and two model DE-001 single-use electrosurgical return electrodes

Device Class : 2

Duns Number: 618493741

Premarket Exempt : No

Product Code : KNF

Prescription Use : Yes

Device Count : 1

Sonata® Intrauterine Ultrasound Probe Return Kit - 10817929020036 Catalog Number : RTN-001

Device Class : 2

Duns Number: 618493741

Premarket Exempt : No

Product Code : ITX

Prescription Use : No

Device Count : 1

Sonata® IUUS Probe Sterile Shipper Kit - 10817929020135 Catalog Number : SHPR-001

Device Description : Sterilization packaging, single use

Device Class : 2

Duns Number: 618493741

Premarket Exempt : No

Product Code : KNF, ITX

Prescription Use : Yes

Device Count : 1

Sonata® IUUS Probe Soaking Cylinder - 10817929020142 Catalog Number : CYL-001

Device Description : General laboratory container, reusable

Device Class : 2

Duns Number: 618493741

Premarket Exempt : Yes

Product Code : IYO, ITX, KNF

Prescription Use : No

Device Count : 1

Sonata® Procedure Kit - 10817929020166 Catalog Number : PROKIT-001

Device Description : Convenience Kit containing one model RFA-002 sterile single-use ultrasound-guide Convenience Kit containing one model RFA-002 sterile single-use ultrasound-guided intrauterine electrosurgical handpiece / electrode, two model DE-001 single-use electrosurgical return electrodes, and one model ACCY-007 sterile single-use electrosurgical handpiece cable.

Device Class : 2

Duns Number: 618493741

Premarket Exempt : No

Product Code : KNF

Prescription Use : Yes

Device Count : 1

Sonata® System Cart - 10817929020180 Catalog Number : ACCY-002

Device Description : Electromechanical device transport trolley

Device Class : 2

Duns Number: 618493741

Premarket Exempt : No

Product Code : IYO, KNF

Prescription Use : Yes

Device Count : 1

Sonata® SMART Tablet - 10817929020197 Catalog Number : USCON-2200

Device Description : Ultrasound -guided intrauterine electrosurgical system ultrasound control unit

Device Class : 2

Duns Number: 618493741

Premarket Exempt : No

Product Code : IYO, KNF

Prescription Use : Yes

Device Count : 1

Sonata® System Radiofrequency Generator - 10817929020203 Catalog Number : RFG2-110

Device Description : Ultrasound-guided intrauterine electrosurgical system generator

Device Class : 2

Duns Number: 618493741

Premarket Exempt : No

Product Code : IYO, KNF

Prescription Use : Yes

Device Count : 1

Sonata® Intrauterine Ultrasound Probe - 10817929020241 Catalog Number : IUSP-002S

Device Description : Ultrasound-guided intrauterine electrosurgical diathermy system intrauterine ult Ultrasound-guided intrauterine electrosurgical diathermy system intrauterine ultrasound transducer, Sterile

Device Class : 2

Duns Number: 618493741

Premarket Exempt : No

Product Code : ITX, KNF

Prescription Use : Yes

Device Count : 1

Sonata® Sonography-Guided Transcervical Fibroid Ablation System - 10817929020326 Catalog Number : SONATA2-110

Device Description : Ultrasound-guided intrauterine electrosurgical system. This system includes a ca Ultrasound-guided intrauterine electrosurgical system. This system includes a cart, ultrasound console, RF generator, and component kit.

Device Class : 2

Duns Number: 618493741

Premarket Exempt : No

Product Code : ITX, KNF, IYO

Prescription Use : Yes

Device Count : 1

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