# K041544: Cook Sidearm Core Tissue Biopsy Device

- Pathway: 510(k) (Traditional)
- Applicant: Urological, Inc.
- Decided: Jul 22, 2004 after 43 days
- Product code: KNW (Instrument, Biopsy)
- 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 K863385 (1986). 5 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K871390: Bard Biopty Biopsy System, C.R. Bard, Inc. (1987) Summary page 1.
- K930083: Ems Biopsy Instrument, Engineered Medical Systems (1993) Summary page 1.
- K905556: High Speed Core Cut Biopsy Gun, Uni-Quatro Industries Canada, Inc. (1991) Summary page 1.
- K914874: Manan Pro-Mag Automatic Biopsy Device, Manan Medical Products, Inc. (1992) Summary page 1.
- K863385: (Roth)Spiral Rotating Prostatic Biopsy Needle, Cook Urological, Inc. (1986) Summary page 1.

## Most influential descendants
- K052435: Pneumrx Family of Biopsy Needles and Kits (2005), 0 descendants of its own

## Indications for use
The Cook-® Sidearm Core Tissue Biopsy Device/Set is used as an automated biopsy instrument to obtain multiple cores of tissue sampling from sites including, but not limited to the prostate, kidney, liver, lung, breast, lymph nodes, and different tumors for histological evaluation.

Source page: https://510kreport.com/device/K041544
Methodology: https://510kreport.com/methodology