Identifiers
- 510(k) Number
- K031084 FDA 510(k)
- FDA Product Code
- FFX FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 876.1725 FDA 510(k)
- Regulation Number
- 876.1725 FDA 510(k)
- Advisory Committee
- Gastroenterology, Urology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Solar GI System is a Class 2 gastrointestinal motility electrical system designed for stationary motility testing in hospitals and private clinics. It provides all the necessary tools for modern manometry examinations with a plug-and-play design developed in cooperation with university hospitals.
The system is manufactured by Medical Measurement Systems B.V. and is supplied for stationary gastrointestinal investigations. It received FDA 510(k) clearance through the Traditional pathway with product code FFX and is intended for use in gastroenterology and urology settings.
Frequently asked questions
What is the Solar GI System used for?
The Solar GI System is a Class 2 gastrointestinal motility electrical system designed for stationary motility testing in hospitals and private clinics. It provides all necessary tools for modern manometry examinations with a plug-and-play design developed in cooperation with university hospitals.
How is the Solar GI System supplied?
The system is supplied for stationary gastrointestinal investigations by Medical Measurement Systems B.V. It is designed for use in gastroenterology and urology settings and comes with all necessary components for manometry examinations.
What is the regulatory status of the Solar GI System?
The Solar GI System received FDA 510(k) clearance through the Traditional pathway with product code FFX. It is classified as a Class 2 device and is intended for use in gastroenterology and urology settings.
What are the key features of the Solar GI System?
The system features a plug-and-play design developed in cooperation with university hospitals. It provides all necessary tools for modern manometry examinations and is specifically designed for stationary gastrointestinal motility testing in clinical environments.
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: K121014 FDA 510(k) - SOLAR GI | Medical Measurement Systems B.V., Solar GI - MKS Medic, PDF Solar GI User's manual - instrumed-surgical.com, PDF Solar GI User's manual - instrumed-surgical.com
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K031084 | Class II | Active |
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Manufacturer
- Manufacturer
- Medical Measurement Systems B.V.
Sources (1)
- FDA 510(k) K031084 24 fields · synced Sep 22, 2026