SoloAsisst II, Voice Control

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K200473

Identifiers

510(k) Number: K200473 FDA 510(k)
FDA Product Code: NAY FDA 510(k)

Classification

Device Class: Class II FDA 510(k)
Legislation / Framework: 21 CFR Part 876.1500 FDA 510(k)
Regulation Number: 876.1500 FDA 510(k)
Advisory Committee: Gastroenterology, Urology FDA 510(k)
FDA Decision: SESE Substantially Equivalent FDA 510(k)

The SoloAssist II Voice Control is a computer-controlled surgical system designed for minimally invasive procedures. It integrates voice-activated controls to assist in endoscopic and urological interventions, enabling precise manipulation of instruments within the gastrointestinal and urinary tracts.

This device is supplied as a reusable system and is intended for use in sterile operating environments. It is classified as a Class II medical device under FDA regulations and has received FDA 510(k) clearance and MDR authorization. The system is compatible with MRI environments and is available in configurations corresponding to the listed FEI numbers for specific procedural applications.

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 (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	MDR	—	Class II	Active
FDA 510(k)	United States	FDA_510K	K200473	Class II	Active

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Manufacturer

Manufacturer: Aktormed GmbH

Sources (2)

FDA 510(k) K200473 24 fields · synced Sep 18, 2026
EUDAMED 1 fields · synced May 19, 2026