510(k) K261573
- Device
- ENDOSCOPE HOLDER (182214)
- Applicant
- Aktormed GmbH
- 510(k) number
- K261573
- Product code
- QZB
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-07-20
- Date received
- 2026-05-12
- Regulation
- 876.1500
- Classification name
- Software Controlled Endoscope And Instrument Holder
- Medical specialty
- Gastroenterology, Urology
- Review panel
- Gastroenterology, Urology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Applicant Contact#
- Contact
- Hanna Kafurke
- Address
- Neugablonzer Strasse 13 Neutraubling DE 93073 93073
FDA Registration Numbers#
- 3011390076
- 3026790309
- 3033118964
Source Documents#
Other 510(k) Records For Product Code QZB#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K250984 | Maestro System (REF100) | Moon Surgical | 2025-06-27 |
| K242323 | Maestro System (REF100) | Moon Surgical | 2025-03-14 |
| K233312 | SOLOASSIST IID / DEXTER ENDOSCOPE ARM (212499); ARTip solo (202426) + ARTip solo voice (202445); SOLOASSIST II (141364) + VOICE CONTROL (171894 | Aktormed GmbH | 2024-08-08 |