# K190715: EndoRotor Console, EndoRotor Catheter, EndoRotor Specimen Trap, EndoRotor Filter Set, EndoRotor Roll Stand

- Pathway: 510(k) (Traditional)
- Applicant: Interscope, Inc.
- Decided: Dec 13, 2019 after 269 days
- Product code: ERL (Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece)
- Device class: 2
- Regulation: 21 CFR 874.4250
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K002224 (2000). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041413: XPS 3000 System, Medtronic Xomed, Inc. (2004) Summary page 4.

## Indications for use
The EndoRotor® System is intended for use in airway procedures including removal of granulation tissue and endobronchial lesions.

Source page: https://510kreport.com/device/K190715
Methodology: https://510kreport.com/methodology