FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
SOLOASSIST IID / DEXTER ENDOSCOPE ARM (212499); ARTip solo (202426) + ARTip solo voice (202445); SOLOASSIST II (141364) + VOICE CONTROL (171894
K Number: K233312
·
Decision Aug 8, 2024
Classifications
1
FEI Numbers
3
Registration Numbers
3
Same Product Code
2
Applicant Total
4
Review Days
314
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Basic Information
- Device Name
- SOLOASSIST IID / DEXTER ENDOSCOPE ARM (212499); ARTip solo (202426) + ARTip solo voice (202445); SOLOASSIST II (141364) + VOICE CONTROL (171894
- K Number
- K233312
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Aktormed GmbH
- Date Received
- September 29, 2023
- Decision Date
- August 8, 2024
- Product Code
- QZB
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- SU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| QZB | Software Controlled Endoscope And Instrument Holder | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (QZB), ordered by most recent decision date.
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