# K163058: Expect Slimline (SL) Endoscopic Ultrasound Aspiration Needle

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific
- Decided: Jan 30, 2017 after 90 days
- Product code: ODG (Endoscopic Ultrasound System, Gastroenterology-Urology)
- Device class: 2
- Regulation: 21 CFR 876.1500
- 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 K935844 (1995). 31 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 33 devices in its family (counting itself) have 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 4.
- K092359: Echo Tip Ultra High Definition Ultrasound Access Needle, Model: Echo-HD-19A, Cook Ireland, Ltd. (2009) Summary page 4.
- K150891: BNX Fine Needle Aspiration System and SharkCore LG Fine Needle Biopsy System, Covidien, LLC ( Formerly Beacon Endoscopic Corp.) (2015) Summary page 4.

## Most influential descendants
- K173184: Expect Slimline (SL) Endoscopic Ultrasound Aspiration Needle (2017), 0 descendants of its own

## Indications for use
The Expect™ Slimline (SL) Needle is designed to sample targeted submucosal and extramural gastrointestinal lesions through the accessory channel of a curvilinear echoendoscope. It can also be used for delivery of injectable materials (fluids) or fiducials into tissue or for passage of accessory devices.

Source page: https://510kreport.com/device/K163058
Methodology: https://510kreport.com/methodology