FDA product code QFZ: Gastroenterology-Urology Accessories To A Biopsy Instrument
QFZ is the FDA product code for gastroenterology-urology accessories to a biopsy instrument. It is a Class I device, regulated under 21 CFR 876.1080 and reviewed by the Gastroenterology and Urology panel. Devices under QFZ reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Definition
A gastroenterology-urology accessory to a biopsy instrument is an accessory used to remove a specimen of tissue for microscopic examination by cutting or aspiration. This generic type of device includes a syringe for specimen aspiration and a biopsy channel adaptor. This device does not include accessories to biopsy instruments used in other medical specialty areas.
Classification
| Field | Value |
|---|---|
| Device name | Gastroenterology-Urology Accessories To A Biopsy Instrument |
| Device class | Class I |
| Regulation | 21 CFR 876.1080 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) exempt |
Recalls for QFZ devices
openFDA lists no recalls for product code QFZ.
Frequently asked questions
What is FDA product code QFZ?
QFZ is the FDA product code for gastroenterology-urology accessories to a biopsy instrument. It is a Class I device, regulated under 21 CFR 876.1080 and reviewed by the Gastroenterology and Urology panel.
What device class is QFZ?
Class I, regulation 21 CFR 876.1080. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code QFZ
- Run a recall and safety report across every QFZ manufacturer
- Watch product code QFZ 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.
All Gastroenterology and Urology product codes · FDA product code lookup