FDA product code QIJ: Endoscopic Transhepatic Venous Access Needle
QIJ is the FDA product code for endoscopic transhepatic venous access needle. It is a Class II device, regulated under 21 CFR 876.1050 and reviewed by the Gastroenterology and Urology panel. Devices under QIJ reach the market by 510(k); FDA lists no cleared 510(k)s for it. 1 De Novo request was granted under it.
Definition
An endoscopic transhepatic venous access needle is inserted through the liver into the patients portal/hepatic venous system under endoscopic ultrasound guidance. It is connected to a separate device intended to measure a physiological parameter.
Classification
| Field | Value |
|---|---|
| Device name | Endoscopic Transhepatic Venous Access Needle |
| Device class | Class II |
| Regulation | 21 CFR 876.1050 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) |
Recalls for QIJ devices
openFDA lists no recalls for product code QIJ.
Frequently asked questions
What is FDA product code QIJ?
QIJ is the FDA product code for endoscopic transhepatic venous access needle. It is a Class II device, regulated under 21 CFR 876.1050 and reviewed by the Gastroenterology and Urology panel.
What device class is QIJ?
Class II, regulation 21 CFR 876.1050. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code QIJ
- Run a recall and safety report across every QIJ manufacturer
- Watch product code QIJ 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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