Clearance Summary
SOLOASSIST IID / DEXTER ENDOSCOPE ARM (212499); ARTip solo (202426) + ARTip solo voice (202445); SOLOASSIST II (141364) + VOICE CONTROL (171894 received FDA 510(k) clearance under submission number K233312, sponsored by Aktormed GmbH. The device was reviewed via the Traditional premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 2024-08-08.
- Submission: K233312
- Applicant / Sponsor: Aktormed GmbH
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1500
- Decision date: 2024-08-08
Classification & Regulation
This clearance is catalogued under FDA product code QZB and 21 CFR 876.1500, within the Gastroenterology, Urology review panel as a Class II device.