FDA.reportPublic FDA data

510(k) K241793

Device
Automatic Core Biopsy Instrument/ Semi-Automatic Core Biopsy Instrument/ Disposable Coaxial Biopsy Needle
Applicant
Zhejiang Curaway Medical Technology Co., Ltd.
510(k) number
K241793
Product code
KNW
Decision
Substantially Equivalent (SESE)
Decision date
2025-01-24
Date received
2024-06-21
Regulation
876.1075
Classification name
Instrument, Biopsy
Medical specialty
Gastroenterology, Urology
Review panel
Gastroenterology, Urology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Li Yin
Address
Rm. 106, Bldg. 1, # 600, 21st Ave., Baiyang Sub-District, Qi Hangzhou CN 310018 310018

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code KNW#

510(k), Device, Applicant table
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