# K863385: (Roth)Spiral Rotating Prostatic Biopsy Needle

- Pathway: 510(k) (Traditional)
- Applicant: Cook Urological, Inc.
- Decided: Nov 4, 1986 after 62 days
- Product code: KNN (Components, Wheelchair)
- Device class: 1
- Regulation: 21 CFR 890.3920
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

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

## Most influential descendants
- K041544: Cook Sidearm Core Tissue Biopsy Device (2004), 1 descendant of its own
- K052435: Pneumrx Family of Biopsy Needles and Kits (2005), 0 descendants of its own

Source page: https://510kreport.com/device/K863385
Methodology: https://510kreport.com/methodology