# K241793: Automatic Core Biopsy Instrument/ Semi-Automatic Core Biopsy Instrument/ Disposable Coaxial Biopsy Needle

- Pathway: 510(k) (Traditional)
- Applicant: Zhejiang Curaway Medical Technology Co., Ltd.
- Decided: Jan 24, 2025 after 217 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: 4 generations back to K950732 (1995). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133948: Bard (R) Monopty (R) Disposable Core Biopsy Instrument, Bard (R) Max-Core (R) Disposable Core Instrument, Bard Peripheral Vascular, Inc. (2014) Summary page 5.
- K141552: Achieve Programmable Auomated Biopsy Systems, Care Fusion (2014) Summary page 5.
- K171953: Bard Mission Disposable Core Biopsy Instrument, Bard Peripheral Vascular, Inc. (2017) Summary page 5.

## Indications for use
Automatic Core Biopsy Instrument is intended for use in obtaining biopsies from soft tissues such as breast, liver, kidney, prostate, spleen, lymph nodes and various soft tissue tumors. It is not intended for use in bone. Semi-Automatic Core Biopsy Instrument is intended for use in obtaining biopsies from soft tissues such as lung, liver, spleen, kidney, prostate, lymph nodes, breast, thyroid, and various soft tissue tumors. It is not intended for use in bone. Disposable Coaxial Biopsy Needle is intended for use as a guiding needle in obtaining core biopsy samples from soft tissue such as lung, liver, spleen, kidney, prostate, lymph nodes, breast, thyroid and various soft tissue tumors. It is designed for use with CuraWay Automatic Core Biopsy Instrument and CuraWay Semi-Automatic Core Biopsy Instrument. It is not intended for use in bone.

Source page: https://510kreport.com/device/K241793
Methodology: https://510kreport.com/methodology