Duns Number:618493741
Device Description: Ultrasound-guided intrauterine electrosurgical system. This system includes a cart, ultras Ultrasound-guided intrauterine electrosurgical system. This system includes a cart, ultrasound console, RF generator, and component kit.
Catalog Number
SONATA2-110
Brand Name
Sonata® Sonography-Guided Transcervical Fibroid Ablation System
Version/Model Number
SONATA2-110
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K173703
Product Code
ITX
Product Code Name
Transducer, Ultrasonic, Diagnostic
Public Device Record Key
1c03567c-972a-4178-a380-6817191eabe2
Public Version Date
August 09, 2019
Public Version Number
2
DI Record Publish Date
May 10, 2019
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 15 |