K233312
- 510(k) number
- K233312
- Device name
- SOLOASSIST IID / DEXTER ENDOSCOPE ARM (212499); ARTip solo (202426) + ARTip solo voice (202445); SOLOASSIST II (141364) + VOICE CONTROL (171894
- Applicant
- Aktormed GmbH DE
- Product code
- QZB — Software Controlled Endoscope And Instrument Holder
- Decision date
- 2024-08-08
- Date received
- 2023-09-29
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 1.3 MB · U.S. public domain
Also available from FDA: K233312.pdf
Official FDA record: K233312
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.