DEVICE: Sonata® Radiofrequency Ablation Handpiece (10817929020371)
Device Identifier (DI) Information
Sonata® Radiofrequency Ablation Handpiece
RFA-002
In Commercial Distribution
RFA-002
Gynesonics, Inc.
RFA-002
In Commercial Distribution
RFA-002
Gynesonics, Inc.
Ultrasound-guided intrauterine electrosurgical handpiece/ electrode
Device Characteristics
Labeling does not contain MRI Safety Information | |
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GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
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58493 | Ultrasound-guided intrauterine radio-frequency ablation system handpiece/electrode |
A hand-held component of an ultrasound-guided intrauterine electrosurgical system consisting of both a handpiece and a monopolar electrode designed to provide an electrical connection between the output terminals of a dedicated electrosurgical generator and the target tissue (uterine fibroids). The handpiece is also used to deploy an introducer and an intrauterine ultrasound transducer. The electrode typically has an array of needle electrodes at the distal end and the device is connected to the generator proximally. The handpiece has two slider mechanisms to enable accurate advancement of the components controlled by an attached spacer. This is a single-use device.
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FDA Product Code
[?]Product Code | Product Code Name |
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KNF | Coagulator-Cutter, Endoscopic, Unipolar (And Accessories) |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K211535 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity |
Storage Environment Temperature: between -20 and 40 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
595d6d08-a99c-4adf-a1e8-b83730fcd7ee
May 26, 2025
3
July 07, 2021
May 26, 2025
3
July 07, 2021
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
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Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
1-650-216-3860
UScustomerservice@gynesonics.com
UScustomerservice@gynesonics.com