DEVICE: Sonata® Radiofrequency Ablation Handpiece (10817929020371)

Device Identifier (DI) Information

Sonata® Radiofrequency Ablation Handpiece
RFA-002
In Commercial Distribution
RFA-002
Gynesonics, Inc.
10817929020371
GS1

1
618493741 *Terms of Use
Ultrasound-guided intrauterine electrosurgical handpiece/ electrode
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
No
No
No

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?
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.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
KNF Coagulator-Cutter, Endoscopic, Unipolar (And Accessories)
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K211535 000
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Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity
Storage Environment Temperature: between -20 and 40 Degrees Celsius
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

595d6d08-a99c-4adf-a1e8-b83730fcd7ee
May 26, 2025
3
July 07, 2021
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
1-650-216-3860
UScustomerservice@gynesonics.com
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