# K160845: Acquire Endoscopic Ultrasound Fine Needle Biopsy (FNB) Device

- Pathway: 510(k) (Special)
- Applicant: Boston Scientific Corporation
- Decided: May 3, 2016 after 36 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: 6 generations back to K904667 (1990). 9 ancestors in all.
4 later devices descend from it; 3 cite it directly.
0 of 14 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.

## Most influential descendants
- K172309: Endoscopic Ultrasound Aspiration Needle (2017), 1 descendant of its own
- K251542: InstaFAN (2025), 0 descendants of its own
- K223616: Acquire™ S Endoscopic Ultrasound Fine Needle Biopsy (FNB) Device (2022), 0 descendants of its own
- K212852: Areus (TM) Adapt Endoscopic Ultrasound Aspiration Needle, Tridemt (TM) Endoscopic Ultrasound Aspiration Needle (2021), 0 descendants of its own

## Indications for use
The Acquire™ Fine Needle Biopsy 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/K160845
Methodology: https://510kreport.com/methodology