# K230778: EndoCore

- Pathway: 510(k) (Traditional)
- Applicant: Praxis Medical, LLC
- Decided: Sep 25, 2023 after 188 days
- Product code: KTI (Bronchoscope Accessory)
- 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: 13 generations back to K894632 (1989). 59 ancestors in all.
No later device cites it as a predicate yet.
1 of 60 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K213060: AreusTM Endobronchial Ultrasound Aspiration Needle, TridentTM Endobronchial Ultrasound Aspiration Needle, Micro-Tech (Nanjing) Co., Ltd. (2022) Summary page 5.

## Indications for use
The Praxis Medical EndoCore is used with ultrasound endoscope to sample targeted submucosal and extramural lesions of the tracheobronchial tree. For any patient 18 years and older requiring tissue sampling.

Source page: https://510kreport.com/device/K230778
Methodology: https://510kreport.com/methodology