# K244018: Disposable Biopsy Needle

- Pathway: 510(k) (Traditional)
- Applicant: Zhejiang Curaway Medical Technology Co., Ltd.
- Decided: Jul 22, 2025 after 207 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: 2 generations back to K970872 (1997). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K970872: Pan (Chiba Aspirating Needle), Gallini Intl., Inc. (1997) Summary page 5.
- K213683: Promisemed Fine Biopsy Needle, Promisemed Hangzhou Meditech Co., Ltd. (2022) Summary page 5.

## Indications for use
Disposable Biopsy Needle is intended for use in soft tissue biopsies such as liver, kidney, breast, thyroid, prostate, spleen, pancreas, lymph nodes, lung and various soft tissue tumors. It is not intended for use in bone.

Source page: https://510kreport.com/device/K244018
Methodology: https://510kreport.com/methodology