Identifiers
- 510(k) Number
- K831766 FDA 510(k)
- FDA Product Code
- FKX FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 876.5630 FDA 510(k)
- Regulation Number
- 876.5630 FDA 510(k)
- Advisory Committee
- Gastroenterology, Urology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Microstar Vci is a System, Peritoneal, Automatic Delivery device, classified as a class 2 device. It is substantially equivalent to other devices and has a regulation number of 876.5630. The device is used in the medical specialty of Gastroenterology and Urology.
The Microstar Vci is supplied with an FDA 510(k) authorization, specifically clearance number K831766. The device has a product code of FKX and is manufactured by Medionics International, Ltd. It is intended for automatic delivery in peritoneal applications, with no additional information on sterility, reuse, or MRI safety provided.
Frequently asked questions
What is the Microstar Vci used for?
The Microstar Vci is used for automatic delivery in peritoneal applications, specifically in the medical specialties of Gastroenterology and Urology.
Is the Microstar Vci sterile?
No information on sterility is provided for the Microstar Vci.
What is the regulatory status of the Microstar Vci?
The Microstar Vci has an FDA 510(k) authorization, specifically clearance number K831766, and is classified as a class 2 device with regulation number 876.5630.
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. Sources consulted: MICROSTAR VCI (K831766) — FDA 510(k) | Innolitics, MEDIONICS INTERNATIONAL, INC. FDA Filings - FDA.report, MICROSTAR VC1 VOLUMETRIC CYCLER (K832141) — FDA 510 (k) | Innolitics, Microstar Vc1 Volumetric Cycler - Beudamed
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K831766 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Medionics International , Ltd.
Sources (1)
- FDA 510(k) K831766 24 fields · synced Sep 24, 2026