FDA product code PZQ: General Laparoscopic Power Morcellation Containment System
PZQ is the FDA product code for general laparoscopic power morcellation containment system. It is a Class II device, regulated under 21 CFR 878.4825 and reviewed by the General and Plastic Surgery panel. Devices under PZQ reach the market by 510(k); FDA lists no cleared 510(k)s for it. 1 De Novo request was granted under it.
Definition
Intended for use as a bag containment system by qualified surgeons for tissue extraction and/or power morcellation during general laparoscopic procedures.
Classification
| Field | Value |
|---|---|
| Device name | General Laparoscopic Power Morcellation Containment System |
| Device class | Class II |
| Regulation | 21 CFR 878.4825 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) |
Recalls for PZQ devices
openFDA lists no recalls for product code PZQ.
Frequently asked questions
What is FDA product code PZQ?
PZQ is the FDA product code for general laparoscopic power morcellation containment system. It is a Class II device, regulated under 21 CFR 878.4825 and reviewed by the General and Plastic Surgery panel.
What device class is PZQ?
Class II, regulation 21 CFR 878.4825. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code PZQ
- Run a recall and safety report across every PZQ manufacturer
- Watch product code PZQ 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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