510(k) K242322

Bone Marrow Biopsy Needle by Zhejiang Curaway Medical Technology Co., Ltd. — Product Code KNW

K242322 is an FDA 510(k) premarket notification submitted by Zhejiang Curaway Medical Technology Co., Ltd. for the device "Bone Marrow Biopsy Needle". The FDA issued a decision of Substantially Equivalent on January 24, 2025. The device falls under product code KNW (Instrument, Biopsy), a Class II device regulated under 21 CFR 876.1075. Zhejiang Curaway Medical Technology Co., Ltd. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 24, 2025
Date Received
August 6, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrument, Biopsy
Device Class
Class II
Regulation Number
876.1075
Review Panel
SU
Submission Type