K233312 is an FDA 510(k) clearance for the SOLOASSIST IID / DEXTER ENDOSCOPE ARM (212499); ARTip solo (202426) + ARTip solo voice (202445); SOLOASSIST II (141364) + VOICE CONTROL (171894. This device is classified as a Software Controlled Endoscope And Instrument Holder (Class II - Special Controls, product code QZB).
Submitted by Aktormed GmbH (Neutraubling, DE). The FDA issued a Cleared decision on August 8, 2024, 314 days after receiving the submission on September 29, 2023.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 876.1500. To Hold And Position Endoscopes And Instruments..
| 510(k) Number | K233312 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 29, 2023 |
| Decision Date | August 08, 2024 |
| Days to Decision | 314 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | QZB — Software Controlled Endoscope And Instrument Holder |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.1500 |
| Definition | To Hold And Position Endoscopes And Instruments. |