FDA.reportPublic FDA data

Sonata® System Cart

Primary DI
10817929020180
Brand
Sonata® System Cart
Company
Gynesonics, Inc.
Model
ACCY-002
Catalog number
ACCY-002
Device description
Electromechanical device transport trolley
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
10817929020180PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1081792902018010817929020180

GMDN Terms#

Term, Definition table
TermDefinition
Electromechanical device/system transport trolleyA mobile (on wheels) cart intended to be used as a carrier for transporting an electromechanical device(s) or a powered system assembly. This trolley (cart) may be designed specifically for a proprietary control unit/system, and will typically have one or more horizontal surfaces where the devices are placed; it may include additional features (e.g., gas cylinder holder, intravenous pole) specific to a proprietary system. Neither electromechanical devices nor system components are included.

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
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10817929020357Sonata® System SoftwareSW-001SW-0012020-02-21
10817929020340Sonata System SoftwareSW-002SW-0022020-10-07
30817929020474Sonata Dispersive ElectrodeDE-0022026-08-25
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
10817929020036Sonata® Intrauterine Ultrasound Probe Return KitRTN-001RTN-0012020-10-07
10817929020166Sonata® Procedure Kit PROKIT-001PROKIT-0012020-10-07
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
10817929020197Sonata® SMART TabletUSCON-2200USCON-22002019-05-10
10817929020203Sonata® System Radiofrequency GeneratorRFG2-110RFG2-1102019-05-10
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
30817929020474Sonata Dispersive ElectrodeGynesonics, Inc.KNF2026-08-25
08800010500840SonoSync+SAMSUNG MEDISON CO., LTD.IYO2026-08-18
08800357291937V6 ONE Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.IYO2026-08-18
08800357300165V7 ONE Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.IYO2026-08-18
08800357308208V8 ONE Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.IYO2026-08-18
00841517112684C5-1FUJIFILM SONOSITE, INC.IYO2026-08-07
00841436125420Tracking BracketCIVCO MEDICAL INSTRUMENTS CO., INC.IYO2026-07-27
00841436126212Tracking Bracket Starter KitCIVCO MEDICAL INSTRUMENTS CO., INC.IYO2026-07-27
00841436126229Tracking BracketCIVCO MEDICAL INSTRUMENTS CO., INC.IYO2026-07-27
00841436126328Tracking BracketCIVCO MEDICAL INSTRUMENTS CO., INC.IYO2026-07-27
00841436126588Tracking Bracket Starter KitCIVCO MEDICAL INSTRUMENTS CO., INC.IYO2026-07-27
00841436126595Tracking BracketCIVCO MEDICAL INSTRUMENTS CO., INC.IYO2026-07-27
00195278713322RIC12-DGE Healthcare Austria GmbH & Co OGIYO2026-07-24
00841436122672Needle GuideCIVCO MEDICAL INSTRUMENTS CO., INC.IYO2026-07-23
00841436125338Biopsy BracketCIVCO MEDICAL INSTRUMENTS CO., INC.IYO2026-07-23
00841436125413Tracking Bracket Starter KitCIVCO MEDICAL INSTRUMENTS CO., INC.IYO2026-07-23
00841436125819Biopsy BracketCIVCO MEDICAL INSTRUMENTS CO., INC.IYO2026-07-23
00841436126281Biopsy BracketCIVCO MEDICAL INSTRUMENTS CO., INC.IYO2026-07-23
00841436126304Biopsy BracketCIVCO MEDICAL INSTRUMENTS CO., INC.IYO2026-07-23
00840432200216BladderScan®VERATHON INCIYO2026-07-22
00841517112011iLOOKFUJIFILM SONOSITE, INC.IYO2026-07-16
00841517112028iLOOKFUJIFILM SONOSITE, INC.IYO2026-07-16
00841517112035iLOOKFUJIFILM SONOSITE, INC.IYO2026-07-16
00841517112462iLOOKFUJIFILM SONOSITE, INC.IYO2026-07-16
00841517139018iLOOKFUJIFILM SONOSITE, INC.IYO2026-07-16
00841436126311Tracking Bracket Starter KitCIVCO MEDICAL INSTRUMENTS CO., INC.IYO2025-12-31
00195278439352LOGIQGE Medical Systems, Ultrasound & Primary Care Diagnostics LLCIYO2025-12-05
00195278439369LOGIQGE Medical Systems, Ultrasound & Primary Care Diagnostics LLCIYO2025-12-05
00195278723963NAGE Healthcare Japan CorporationIYO2025-10-15
00195278875860VscanGE Vingmed Ultrasound A/SIYO2025-07-04