Product Code: QZB
FDA class 2
21 CFR 876.1500
Software Controlled Endoscope And Instrument Holder
Gastroenterology, Urology
The software-controlled endoscope and instrument holder (product code QZB) is a Class 2 Gastroenterology/Urology device (regulation 876.1500) designed to hold and position endoscopes and surgical instruments during procedures. It requires 510(k) clearance and is reviewed by the Surgery panel. It is not an implant and is not life-sustaining.
510(k)s
3
FEI Numbers
4
Registration Numbers
4
Unique Applicants
2
Years Active
1
Basic Information
- Product Code
- QZB
- Device Class
- FDA class 2
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Review Panel
- SU
- Submission Type
- 1
Device Characteristics
✗
GMP Exempt
✗
Implant
✗
Life Sustain/Support
✗
Third Party
—
Summary Malfunction Reporting
Definition
To hold and position endoscopes and instruments.
510(k) Clearance History
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Related 510(k) Clearances
This FDA classification is associated with 3 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K250984 | Maestro System (REF100) | Jun 27, 2025 | Substantially Equivalent | Moon Surgical |
| K242323 | Maestro System (REF100) | Mar 14, 2025 | Substantially Equivalent | Moon Surgical |
| K233312 | SOLOASSIST IID / DEXTER ENDOSCOPE ARM (212499); ARTip solo (202426) + ARTip solo voice (202445); SOLOASSIST II (141364) + VOICE CONTROL (171894 | Aug 08, 2024 | Substantially Equivalent | AKTORmed GmbH |
FEI Numbers
This FDA classification entry is associated with 4 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 4 registration numbers. Click on an entry to view related FDA registrations.