FDA product code QNE

Endoscopic Pancreatic Debridement Device

Gastroenterology, Urology·Class 2·21 CFR 876.4330
US regulatory classifications
US Product Code (FDA)
QNE
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US Risk Class (FDA)
Class 2
US Regulation (CFR)
21 CFR 876.4330
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Medical specialty
Gastroenterology, Urology
Device characteristics
GMP exempt
No
Implantable
No
Life-sustaining
No
Third party review
Not Eligible
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.

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About this record

Endoscopic Pancreatic Debridement Device is a medical device type in the Gastroenterology, Urology specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.

View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.