510(k) K233312

Device

SOLOASSIST IID / DEXTER ENDOSCOPE ARM (212499); ARTip solo (202426) + ARTip solo voice (202445); SOLOASSIST II (141364) + VOICE CONTROL (171894

Applicant

Aktormed GmbH

510(k) number

K233312

Product code

QZB

Decision

Substantially Equivalent (SESE)

Decision date

2024-08-08

Date received

2023-09-29

Regulation

876.1500

Classification name

Software Controlled Endoscope And Instrument Holder

Medical specialty

Gastroenterology, Urology

Review panel

Gastroenterology, Urology

Device class

2

Clearance type

Traditional

Statement or summary

Summary

Third party reviewed

No