# DEN200016: EndoRotor Device

- Pathway: De Novo (Direct)
- Applicant: Interscope, Inc.
- Decided: Dec 23, 2020 after 282 days
- Product code: QNE (Endoscopic Pancreatic Debridement Device)
- Device class: 2
- Regulation: 21 CFR 876.4330
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Indications for use
The EndoRotor device is indicated to resect and remove necrotic tissue in symptomatic Walled off pancreatic necrosis /Walled off necrosis (WOPN/WON) after having undergone endoscopic ultrasound (EUS) guided drainage.

Source page: https://510kreport.com/device/DEN200016
Methodology: https://510kreport.com/methodology