# K171596: ECHO-3-22: Echotip Ultra and EUSN-1, EUSN-3: Echotip Ultrasound Needle

- Pathway: 510(k) (Traditional)
- Applicant: Wilson-Cook Medical, Inc.
- Decided: Aug 4, 2017 after 65 days
- Product code: FCG (Biopsy Needle)
- Device class: 2
- Regulation: 21 CFR 876.1075
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K934356 (1994). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 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 4.

## Indications for use
This device is used to sample targeted submucosal gastrointestinal lesions through the accessory channel of an ultrasound endoscope. The target population is adult use only.

Source page: https://510kreport.com/device/K171596
Methodology: https://510kreport.com/methodology