# K973565: Quick-Care Biopsy Needle

- Pathway: 510(k) (Traditional)
- Applicant: Cook, Inc.
- Decided: Nov 3, 1997 after 45 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
No predicates in its family tree.
2 later devices descend from it; 2 cite 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. The FDA summary names its predicate without a number.
- (no number) ProAct Biopsy Needle: named in the summary without a submission number

## Most influential descendants
- K193268: APrioCore Plus (2020), 0 descendants of its own
- K142791: Spectra Soft Tissue Biopsy Needles (2015), 0 descendants of its own

## Indications for use
Used for soft tissue biopsy. Supplied sterile in peel-open packages Intended for single procedure use.

Source page: https://510kreport.com/device/K973565
Methodology: https://510kreport.com/methodology