SOLOASSIST IID / DEXTER ENDOSCOPE ARM (212499); ARTip solo (202426) + ARTip solo voice (202445); SOLOASSIST II (141364) + VOICE CONTROL (171894
FDA 510(k) clearance K233312 · decided 2024-08-08
Clearance details
- 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
- Decision
- Substantially Equivalent
- Date received
- 2023-09-29
- Decision date
- 2024-08-08
- Days to decision
- 314 days
- Clearance type
- Traditional
- Product code
- QZB
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Neutraubling, DE
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| ENDOSCOPE HOLDER (182214) (K261573) | Aktormed GmbH | 2026-07-20 |
| Maestro System (REF100) (K250984) | Moon Surgical | 2025-06-27 |
| Maestro System (REF100) (K242323) | Moon Surgical | 2025-03-14 |
Recalls involving this device
No recalls on record reference this clearance.