# K110030: Expect Endoscopic Aspiration Needle

- Pathway: 510(k) (Special)
- Applicant: Boston Scientific Corp
- Decided: Jan 12, 2011 after 7 days
- Product code: ODG (Endoscopic Ultrasound System, Gastroenterology-Urology)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K904667 (1990). 7 ancestors in all.
26 later devices descend from it; 2 cite it directly.
0 of 34 devices in its family (counting itself) have a Class I recall.

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

## Most influential descendants
- K112198: Expect Endoscopic Ultrasound Aspiration Needle (2011), 16 descendants of its own
- 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
- K133312: Expect Slimline Endoscopic Ultrasound Aspiration Needle (2014), 8 descendants of its own

## Recalls of this device
- Aug 11, 2011 · Not classified · Z-3215-2011: The firm has determined that a single lot of 25 ga Expect EUS/FNA devices were mislabeled. The carton label incorrectly described the devices as 22 ga. The inner pouch label incorrectly describes the 

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

Source page: https://510kreport.com/device/K110030
Methodology: https://510kreport.com/methodology