# K151895: Expect Pulmonary Endobronchial Ultrasound Transbronchial Aspiration Needle

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Corporation
- Decided: Oct 22, 2015 after 104 days
- Product code: FCG (Biopsy Needle)
- Device class: 2
- Regulation: 21 CFR 876.1075
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 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)
- K133312: Expect Slimline Endoscopic Ultrasound Aspiration Needle, Boston Scientific Corporation (2014) Summary page 5.
- K050503: Single Use Aspiration Needle NA-201SX-4022, Olympus Medical Systems Corporation (2005) Summary page 5.

## Indications for use
The Expect™ Pulmonary Endobronchial Ultrasound Transbronchial Aspiration Needle is designed to be used with endobronchial ultrasound endoscopes for ultrasound guided fine needle aspiration (FNA) of the submucosal and extramural lesions of the gastrointestinal tract. Do no use this instrument for any purpose other than its intended use.

Source page: https://510kreport.com/device/K151895
Methodology: https://510kreport.com/methodology