# K183085: CoreDx™ Pulmonary Mini-Forceps

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Corporation
- Decided: Mar 8, 2019 after 122 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: 11 generations back to K894632 (1989). 57 ancestors in all.
No later device cites it as a predicate yet.
1 of 58 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K163248: Expect Pulmonary Endobronchial Ultrasound Transbronchial Aspiration Needle, Boston Scientific Corporation (2017) Summary page 4.

## Indications for use
The CoreDx Pulmonary Mini-Forceps are specifically designed to collect tissue endoscopically for histologic examination. These forceps can be used with endobronchial ultrasound endoscopes for ultrasound guided mini-forceps biopsy (MFB) of submucosal and extramural lesions of the tracheobronchial tree. These forceps should not be used for any purpose other than their intended use.

Source page: https://510kreport.com/device/K183085
Methodology: https://510kreport.com/methodology