GYNESONICS, INC.

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

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Filters

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) (6) Transducer, Ultrasonic, Diagnostic (ITX) (2) System, Imaging, Pulsed Echo, Ultrasonic (IYO) (1)

Premarket Exempt

No Yes

Clear

Sonata System Software - 10817929020340 Catalog Number : SW-002

Device Class : 2

Duns Number: 618493741

Premarket Exempt : No

Product Code : KNF

Prescription Use : Yes

Device Count : 1

Sonata® System Software - 10817929020357 Catalog Number : SW-001

Device Description : Ultrasound-guided radio-frequency ablation system software

Device Class : 2

Duns Number: 618493741

Premarket Exempt : No

Product Code : KNF, ITX, IYO

Prescription Use : Yes

Device Count : 1

Sonata® Dispersive Electrode - 10817929020364 Catalog Number : DE-001

Device Description : Electrosurgical return electrode, single-use

Device Class : 2

Duns Number: 618493741

Premarket Exempt : No

Product Code : KNF

Prescription Use : Yes

Device Count : 1

Sonata® Radiofrequency Ablation Handpiece - 10817929020371 Catalog Number : RFA-002

Device Description : Ultrasound-guided intrauterine electrosurgical handpiece/ electrode

Device Class : 2

Duns Number: 618493741

Premarket Exempt : No

Product Code : KNF

Prescription Use : Yes

Device Count : 1

Sonata® Intrauterine Ultrasound Probe - 30817929020092 Catalog Number : IUSP-002

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

Device Class :

Duns Number: 618493741

Premarket Exempt : No

Product Code : ITX, KNF

Prescription Use : Yes

Device Count : 1

Sonata® RFA Handpiece Cable, Reusable - 30817929020177 Catalog Number : ACCY-008

Device Description : Electrical-only medical device connection cable, reusable

Device Class : 2

Duns Number: 618493741

Premarket Exempt : No

Product Code : KNF

Prescription Use : Yes

Device Count : 1

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