# K200278: CytoCore

- Pathway: 510(k) (Traditional)
- Applicant: Praxis Medical, LLC
- Decided: Mar 31, 2020 after 56 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 K972496 (1997). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K972496: Pencil-Grip Fna Syringe Holder and Effortless Needle Remover, Tao & Tao Technologyt, Inc. (1997) Summary page 4.

## Indications for use
The CytoCore is a device to hold a syringe for performing a biopsy of an identified mass with one hand.

Source page: https://510kreport.com/device/K200278
Methodology: https://510kreport.com/methodology