# K083049: Tornado Rotatabel Snare and Polyp Catcher

- Pathway: 510(k) (Traditional)
- Applicant: Horizons Intl. Corp.
- Decided: Dec 23, 2008 after 70 days
- Product code: FDI (Snare, Flexible)
- Device class: 2
- Regulation: 21 CFR 876.4300
- 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
Horizons Rotatabel Snare and Polyp Catcher TORNADOTM is intended to Electrosurgically Remove and collect Polyps from the Gastro Intestinal Tract Under Endoscopic Visualization.

Source page: https://510kreport.com/device/K083049
Methodology: https://510kreport.com/methodology