# K040018: Excelon Transbronchial Aspiration Needle, Models 6410, 6411, 6412

- Pathway: 510(k) (Special)
- Applicant: Boston Scientific Corp
- Decided: Jan 20, 2004 after 14 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: 2 generations back to K914181 (1991). 2 ancestors in all.
17 later devices descend from it; 2 cite it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K963252: TBAN, Boston Scientific Corp (1996) Summary page 1.

## Most influential descendants
- K142839: GenCut Core Biopsy System (2015), 15 descendants of its own
- K163537: Arcpoint pulmonary needle - 18 ga, Arcpoint pulmonary needle - 21 ga (2017), 14 descendants of its own
- K182188: Ion Endoluminal System ; Flexision Biopsy Needle (2019), 12 descendants of its own
- K202370: Ion Endoluminal System (2020), 5 descendants of its own
- K220299: Ion Endoluminal System (IF1000) (2022), 4 descendants of its own

## Indications for use
Indicated for use in aspiration in carinal, paratracheal and hilar lesions of the bronchial tree where biopsy forceps cannot obtain a submucosal sample.

Source page: https://510kreport.com/device/K040018
Methodology: https://510kreport.com/methodology