Bellota Sonohysterography Catheter With Cervical Cone, Bellota Sonohysterograph…
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K102898 FDA 510(k)
- FDA Product Code
- LKF FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 884.4530 FDA 510(k)
- Regulation Number
- 884.4530 FDA 510(k)
- Advisory Committee
- Obstetrics/Gynecology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Belotta Sonohysterography Catheter is a uterine cannula and manipulator/injector device used for sonohysterography procedures. It is available in two configurations: with cervical cone and without cervical cone. This device is designed for use in obstetrics and gynecology settings.
The device is supplied as a Class II medical device with FDA 510(k) clearance under product code LKF. It is manufactured by Panpac Medical Corporation and has a K-number K102898. The device is not specified as single-use or reusable, and no information regarding sterility, MRI safety, or storage conditions is provided in the data.
Frequently asked questions
What is the Belotta Sonohysterography Catheter used for?
The Belotta Sonohysterography Catheter is a uterine cannula and manipulator/injector device specifically designed for sonohysterography procedures in obstetrics and gynecology settings to help visualize the uterine cavity.
What configurations are available for the Belotta Sonohysterography Catheter?
The Belotta Sonohysterography Catheter is available in two configurations: with cervical cone and without cervical cone, allowing clinicians to choose the appropriate option for their specific procedure needs.
Is the Belotta Sonohysterography Catheter single-use or reusable?
The device data does not specify whether the Belotta Sonohysterography Catheter is designed for single-use or reusable purposes, so clinicians should refer to the manufacturer's instructions for use to determine the appropriate handling protocol.
What regulatory clearance does the Belotta Sonohysterography Catheter have?
The Belotta Sonohysterography Catheter has FDA 510(k) clearance under product code LKF with K-number K102898, classified as a Class II medical device for uterine cannula and manipulator/injector use in obstetrics and gynecology procedures.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K102898 | Class II | Active |
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Manufacturer
- Manufacturer
- Panpac Medical Corporation
Sources (1)
- FDA 510(k) K102898 24 fields · synced Sep 23, 2026