# K200702: EasyPath RF Introducer Sheath

- Pathway: 510(k) (Traditional)
- Applicant: Broncus Medical, Inc.
- Decided: Jan 14, 2021 after 302 days
- Product code: EOQ (Bronchoscope (Flexible Or Rigid))
- Device class: 2
- Regulation: 21 CFR 874.4680
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K955247 (1996). 8 ancestors in all.
No later device cites it as a predicate yet.
1 of 9 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K183240: Empower RF Catheter, Broncus Medical, Inc. (2019) Summary page 4.
- K131234: Lungpoint Tools (Lungpoint Sheath, Lungpoint Dilation Balloon), Broncus Medical, Inc. (2013) Summary page 4.

## Indications for use
The EasyPath RF Introducer Sheath is a single-use device intended to be used with flexible bronchoscopes as a working channel through which endoscopic tools may be introduced to target tissue. It is indicated for electrosurgical procedures involving cutting and coagulation of soft tissue in the upper airways and tracheobronchial tree.

Source page: https://510kreport.com/device/K200702
Methodology: https://510kreport.com/methodology