# K926559: Proact Biopsy Needle Enchancements

- Pathway: 510(k) (Traditional)
- Applicant: Proact, Ltd.
- Decided: Mar 22, 1993 after 81 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
No predicates in its family tree.
4 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K013356: Wilson-Cook Ultrasound Biopsy Needle (2001), 3 descendants of its own
- 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

Source page: https://510kreport.com/device/K926559
Methodology: https://510kreport.com/methodology