# K100712: Resound Endoscopic Ultrasound Aspiration Needle

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Corporation
- Decided: Mar 30, 2010 after 18 days
- Product code: FCG (Biopsy Needle)
- Device class: 2
- Regulation: 21 CFR 876.1075
- Recalls of this device: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K904667 (1990). 6 ancestors in all.
27 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)
- K934356: Wilson-Cook GI Aspiration Needle, Wilson-Cook Medical, Inc. (1994) Summary page 1.
- K023272: Disposable Aspiration Needle NA-200H, The Olympus Optical Co. (2002) Summary page 1.

## Most influential descendants
- K110030: Expect Endoscopic Aspiration Needle (2011), 26 descendants of its own
- 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

## 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 
- Oct 20, 2010 · Not classified · Z-0809-2011: The firm has received a high number of complaints related to difficulty advancing and/or retracting the needle.
- Oct 20, 2010 · Not classified · Z-0810-2011: The firm has received a high number of complaints related to difficulty advancing and/or retracting the needle.
- Oct 20, 2010 · Not classified · Z-0811-2011: The firm has received a high number of complaints related to difficulty advancing and/or retracting the needle.
- Oct 20, 2010 · Not classified · Z-0812-2011: The firm has received a high number of complaints related to difficulty advancing and/or retracting the needle.

## Indications for use
The Resound EUS-FNA device is designed to sample targeted submucosal and extramural gastrointestinal lesions through the accessory channel of a curvilinear echoendoscope.

Source page: https://510kreport.com/device/K100712
Methodology: https://510kreport.com/methodology