# K183240: Empower RF Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Broncus Medical, Inc.
- Decided: Feb 22, 2019 after 94 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K955247 (1996). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120909: EC 2.7 Endoscopic Cutter, Medtronic Advanced Energy, LLC (2012) Summary page 4.

## Most influential descendants
- K200702: EasyPath RF Introducer Sheath (2021), 0 descendants of its own

## Indications for use
The Empower RF Catheter is a single-use, electrosurgical device designed to be used with flexible bronchoscopes. It is indicated for electrosurgical procedures involving soft tissue obstructions in the upper airways and tracheobronchial tree.

Source page: https://510kreport.com/device/K183240
Methodology: https://510kreport.com/methodology