SOLOASSIST IID / DEXTER ENDOSCOPE ARM (212499) +2 more models
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K233312 FDA 510(k)
- FDA Product Code
- QZB FDA 510(k)
- Models / Variants
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 Dexter Endoscope Arm is a software-controlled endoscope and instrument holder designed to assist in minimally invasive surgical procedures. It functions as an articulated robotic arm to hold and position rigid laparoscopes or endoscopes, providing stable and precise control for surgeons. This device is classified as a Class II medical device under FDA regulations, intended for use in specialties such as gastroenterology and urology. The ARTip Solo and ARTip Solo Voice components enhance functionality with voice-controlled adjustments, improving ergonomics and ease of use during procedures.
The SOLOASSIST II system is supplied as a reusable medical device, intended for use in operating rooms and surgical suites. It is regulated under FDA 510(k) clearance (K233312) and the EU Medical Device Regulation (MDR). The device is designed for compatibility with standard endoscope sizes and is controlled via software interfaces, including voice commands for the ARTip Solo Voice module. Storage and handling follow standard surgical instrument protocols, ensuring sterility and functionality for repeated use in clinical settings.
Frequently asked questions
What specialties is the SOLOASSIST II Dexter Endoscope Arm primarily intended for in clinical use?
The SOLOASSIST II Dexter Endoscope Arm is designed for use in gastroenterology and urology specialties, as indicated by its advisory committee classification and regulatory submissions. Its articulated robotic arm and precise control assist surgeons in minimally invasive procedures common to these fields, such as endoscopic examinations or laparoscopic surgeries.
Is the SOLOASSIST II system reusable, and how should it be maintained for repeated use?
Yes, the SOLOASSIST II system is intended for reuse in operating rooms and surgical suites. Maintenance follows standard surgical instrument protocols to ensure sterility and functionality. Since it is a reusable medical device, proper cleaning, disinfection, and storage procedures must be adhered to between uses, as outlined in the manufacturer’s instructions for handling robotic surgical equipment.
What additional features does the ARTip Solo Voice module provide, and how does it enhance the user experience?
The ARTip Solo Voice module adds voice-controlled adjustments to the SOLOASSIST II system, allowing surgeons to operate the endoscope arm hands-free. This feature improves ergonomics by reducing the need for manual controls, enabling smoother and more intuitive positioning during procedures—particularly beneficial in complex or time-sensitive surgeries.
How is the SOLOASSIST II system regulated, and what does its classification mean for clinical adoption?
The SOLOASSIST II system is classified as a Class II medical device under FDA regulations and has received FDA 510(k) clearance (K233312). This classification indicates it undergoes stricter regulatory oversight than Class I devices but does not require the same rigorous premarket approval process as Class III. Clinically, this means it has been deemed substantially equivalent to a legally marketed predicate device, ensuring its safety and effectiveness for use in minimally invasive procedures.
What types of endoscopes or instruments is the SOLOASSIST II Dexter Endoscope Arm compatible with?
The SOLOASSIST II Dexter Endoscope Arm is designed for compatibility with standard rigid laparoscopes or endoscopes commonly used in gastroenterology and urology. Its articulated robotic arm is engineered to securely hold and position these instruments with precision, though specific compatibility should be verified with the manufacturer’s documentation for optimal performance and safety.
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: SOLOASSIST IID / DEXTER ENDOSCOPE ARM (212499); ARTip solo (202426 ..., PDF K233312 - Soloassist Iid / Dexter Endoscope Arm (212499), K233312 FDA 510 (k) - SOLOASSIST IID / DEXTER ENDOSCOPE ARM (..., K233312 · SOLOASSIST IID / DEXTER… · DeviceClearance, K233312 · SOLOASSIST IID / DEXTER… · DeviceClearance
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K233312 | Class II | Active |
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Manufacturer
- Manufacturer
- Aktormed GmbH
Sources (2)
- FDA 510(k) K233312 24 fields · synced Oct 6, 2026
- EUDAMED 1 fields · synced May 18, 2026