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Sonata® Case Kit

FDA UDI

Class II (US FDA UDI)

by Gynesonics, Inc.

Identity

Trade Name
Sonata® Case Kit FDA UDI
Generic Name
Obstetrical/gynaecological surgical procedure kit, non-medicated, single-use FDA UDI
Device Name
Convenience Kit containing one model RFA-001 sterile single-use ultrasound-guided intrauterine electrosurgical handpiece / electrode, and two model DE-001 single-use electrosurgical return electrodes FDA UDI
Model / Reference
CSKIT-001 FDA UDI
Description
Convenience Kit containing one model RFA-001 sterile single-use ultrasound-guided intrauterine electrosurgical handpiece / electrode, and two model DE-001 single-use electrosurgical return electrodes FDA UDI

Identifiers

Catalog Number
CSKIT-001 FDA UDI
Primary DI / UDI-DI
10817929020005 FDA UDI
510(k) Number
K173703 FDA UDI
FDA Product Code
KNF FDA UDI
GMDN Term
Obstetrical/gynaecological surgical procedure kit, non-medicated, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
884.4160 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Sonata® Case Kit by Gynesonics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K173703 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Gynesonics, Inc.

Sources (1)

  • FDA UDI c0baaf06-6121-4d62-83fa-e2573dfbe419 38 fields · synced Jun 1, 2026