Class Class II
Disposable Biopsy Needle (K244018)
Description
Disposable Biopsy Needle by Zhejiang Curaway Medical Technology Co., Ltd., an FDA 510(k) cleared gastroenterology, urology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK244018
Clearance Date2025-07-22
Clearance TypeTraditional
Product CodeKNW
Regulation Number876.1075
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K244018
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. Disposable Biopsy Needle (K244018) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K213683 | Promisemed Fine Biopsy Needle | Promisemed Hangzhou Meditech Co., Ltd. | 2022 |
Trace the full predicate network for K244018
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.