QNE · Class II · 21 CFR 876.4330

FDA Product Code QNE: Endoscopic Pancreatic Debridement Device

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.

Leading manufacturers include Interscope, Inc..

Total

Cleared

282d

Avg days

2020

Since

FDA 510(k) Cleared Endoscopic Pancreatic Debridement Device Devices (Product Code QNE)

1 devices

1–1 of 1

Not Cleared Dec 23, 2020

EndoRotor Device

DEN200016

Interscope, Inc.

Gastroenterology & Urology · 282d

About Product Code QNE - Regulatory Context

Related FDA 510(k) Regulatory Insights

What is a Predicate Device in FDA 510(k)?
What is an FDA Product Code?
What is 510(k) Clearance?
Browse all Gastroenterology & Urology FDA 510(k) clearances
FDA 510(k) regulatory consulting firms ranked by submission volume
FDA 510(k) submission cost and user fees FY 2026

Data Source

FDA 510(k) public files . 175,218 total devices indexed.

Latest clearance: Dec 23, 2020

Product Code Info

Code	QNE
Device class	Class II
CFR	21 CFR 876.4330
Panel	Gastroenterology & Urology

Verify on FDA.gov

View QNE classification on FDA.gov →