# K980046: Bronchial Catheter System

- Pathway: 510(k) (Traditional)
- Applicant: Broncus Technologies, Inc.
- Decided: May 1, 1998 after 115 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
No predicates in its family tree.
44 later devices descend from it; 2 cite it directly.
0 of 45 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Olympus Disposable Balloon Catheters: named in the summary without a submission number
- (no number) Boston Scientific Microvasive Gold Probe Direct: named in the summary without a submission number
- (no number) Valleylab, Inc. Force 2 Electrosurgical Generator: named in the summary without a submission number

## Most influential descendants
- K023765: Stellartech Coagulation System (Models 1100C-115 & 1100C-230) (2002), 42 descendants of its own
- K013139: Stellartech Coagulation System (2001), 42 descendants of its own
- K032062: Stellartech Coagulation System, Models  (1100C-115 & 1100C-230) (2003), 41 descendants of its own
- K032452: Modification to: Stellartech Coagulation System, Models 1100C-115 & 100C-230 (2003), 39 descendants of its own
- K032721: Modification to: Stellartech Coagulation System (Models 1100C-115 & 1100C-230) (2003), 38 descendants of its own

## Indications for use
The Bronchial Catheter System is intended for foreign body removal and bronchial hemostasis.

Source page: https://510kreport.com/device/K980046
Methodology: https://510kreport.com/methodology