FDA product code QNE: Endoscopic Pancreatic Debridement Device
QNE is the FDA product code for endoscopic pancreatic debridement device. It is a Class II device, regulated under 21 CFR 876.4330 and reviewed by the Gastroenterology and Urology panel. Devices under QNE 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 pancreatic debridement device is inserted via an endoscope and placed through a cystogastrostomy fistula into the pancreatic cavity. It is intended for removal of necrotic tissue from a walled off pancreatic necrosis (WOPN) cavity.
Classification
| Field | Value |
|---|---|
| Device name | Endoscopic Pancreatic Debridement Device |
| Device class | Class II |
| Regulation | 21 CFR 876.4330 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) |
Recalls for QNE devices
openFDA lists no recalls for product code QNE.
Frequently asked questions
What is FDA product code QNE?
QNE is the FDA product code for endoscopic pancreatic debridement device. It is a Class II device, regulated under 21 CFR 876.4330 and reviewed by the Gastroenterology and Urology panel.
What device class is QNE?
Class II, regulation 21 CFR 876.4330. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code QNE
- Run a recall and safety report across every QNE manufacturer
- Watch product code QNE 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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