# K142839: GenCut Core Biopsy System

- Pathway: 510(k) (Traditional)
- Applicant: Covidien, LLC
- Decided: Apr 29, 2015 after 211 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: 3 generations back to K914181 (1991). 3 ancestors in all.
15 later devices descend from it; 1 cites it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K914181: Wang/Mill-Rose Transbronchial Aspiration Needle, Mill-Rose Laboratory (1991) Summary page 4.
- K040018: Excelon Transbronchial Aspiration Needle, Models 6410, 6411, 6412, Boston Scientific Corp (2004) Summary page 4.

## Most influential descendants
- 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
- K232984: Ion Endoluminal System (IF1000) (2023), 3 descendants of its own

## Indications for use
The GenCut core biopsy system is utilized through a flexible endoscope or with the superDimension™ navigation system by physicians who are trained in endoscopic techniques for retrieving specimens from patients with endobronchial lesions, peripheral lung nodules, or lung masses.

Source page: https://510kreport.com/device/K142839
Methodology: https://510kreport.com/methodology