FDA product code QZB: Software Controlled Endoscope And Instrument Holder
QZB is the FDA product code for software controlled endoscope and instrument holder. It is a Class II device, regulated under 21 CFR 876.1500 and reviewed by the General and Plastic Surgery panel. FDA has cleared 4 510(k) submissions under QZB, 4 in the last five years, from 2 different applicants. The average 510(k) review took 173 days (median 154); 179 days on average over the last three years.
Definition
To hold and position endoscopes and instruments.
Classification
| Field | Value |
|---|---|
| Device name | Software Controlled Endoscope And Instrument Holder |
| Device class | Class II |
| Regulation | 21 CFR 876.1500 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) |
510(k) clearances per year for QZB
| Year | Clearances | Avg. review days |
|---|---|---|
| 2024 | 1 | 314 |
| 2025 | 2 | 154 |
| 2026 | 1 | 69 |
Compare with all 510(k) review times · Search every QZB clearance
Top QZB applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Aktormed GmbH | 2 | 2026-07-20 |
| Moon Surgical | 2 | 2025-06-27 |
Most recent QZB clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K261573 | Aktormed GmbH | ENDOSCOPE HOLDER (182214) | 2026-07-20 | 69 |
| K250984 | Moon Surgical | Maestro System (REF100) | 2025-06-27 | 88 |
| K242323 | Moon Surgical | Maestro System (REF100) | 2025-03-14 | 220 |
| K233312 | Aktormed GmbH | SOLOASSIST IID / DEXTER ENDOSCOPE ARM (212499); ARTip solo (202426) + ARTip solo voice (202445); SOLOASSIST II (141364) + VOICE CONTROL (171894 | 2024-08-08 | 314 |
Recalls for QZB devices
openFDA lists no recalls for product code QZB.
Frequently asked questions
What is FDA product code QZB?
QZB is the FDA product code for software controlled endoscope and instrument holder. It is a Class II device, regulated under 21 CFR 876.1500 and reviewed by the General and Plastic Surgery panel.
What device class is QZB?
Class II, regulation 21 CFR 876.1500. Typical premarket route: 510(k).
How long does a 510(k) take for product code QZB?
Across 4 cleared submissions the average was 173 days from receipt to decision (median 154).
Which companies have the most QZB clearances?
Aktormed GmbH (2); Moon Surgical (2).
Next steps
- Run an FDA pathway report with predicate devices for product code QZB
- Run a recall and safety report across every QZB manufacturer
- Watch product code QZB for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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