# K112198: Expect Endoscopic Ultrasound Aspiration Needle

- Pathway: 510(k) (Special)
- Applicant: Boston Scientific Corporation
- Decided: Sep 14, 2011 after 44 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: 5 generations back to K904667 (1990). 8 ancestors in all.
16 later devices descend from it; 2 cite it directly.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110030: Expect Endoscopic Aspiration Needle, Boston Scientific Corp (2011) Summary page 2.
- K100712: Resound Endoscopic Ultrasound Aspiration Needle, Boston Scientific Corporation (2010) Summary page 1.

## Most influential descendants
- K123676: Cellvizio 100 Series and Cellvizio Systems with Confocal Miniprobes (2013), 11 descendants of its own
- K132389: Cellvizio 100 Series System and Cellvizio System with Confocal Miniprobes; Uroflex B and Cystolflex F (Both Trade Marked (2014), 10 descendants of its own
- K141358: Cellvizio 100 Series with System Confocal Miniprobes (2014), 9 descendants of its own
- K160416: CystoFlex UHD R-C, CelioFlex UHD 5-C, Cellvizio 100 Series (800) with Confocal Miniprobes (2016), 7 descendants of its own
- K150831: Cellvizio 100 Series System with Confocal Miniprobes (2015), 7 descendants of its own

## Indications for use
The Expect Tm Needle is designed to sample targeted submucosal and extramural lesions through the accessory channel of a curvilinear echoendoscope.

Source page: https://510kreport.com/device/K112198
Methodology: https://510kreport.com/methodology