# K013356: Wilson-Cook Ultrasound Biopsy Needle

- Pathway: 510(k) (Special)
- Applicant: Wilson-Cook Medical, Inc.
- Decided: Oct 19, 2001 after 9 days
- Product code: FCG (Biopsy Needle)
- Device class: 2
- Regulation: 21 CFR 876.1075
- 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: 1 generation back to K926559 (1993). 2 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K926559: Proact Biopsy Needle Enchancements, Proact, Ltd. (1993) Summary page 1.
- K934356: Wilson-Cook GI Aspiration Needle, Wilson-Cook Medical, Inc. (1994) Summary page 1.

## Most influential descendants
- K083802: Sonotip II 25-Gauge Ultrasound Needle System, Models Gus-01-18-025 and Gus-01-27-025 (2009), 2 descendants of its own
- K172309: Endoscopic Ultrasound Aspiration Needle (2017), 1 descendant of its own
- K212852: Areus (TM) Adapt Endoscopic Ultrasound Aspiration Needle, Tridemt (TM) Endoscopic Ultrasound Aspiration Needle (2021), 0 descendants of its own

## Recalls of this device
- Apr 23, 2002 · Not classified · Z-0079-04: There is a possibility that the affected devices would not capture a biopsy during a procedure.

## Indications for use
Used for soft tissue biopsy through the accessory channel of an uitrasound endoscope.

Source page: https://510kreport.com/device/K013356
Methodology: https://510kreport.com/methodology