Atlas FDA

Automatic Core Biopsy Instrument/ Semi-Automatic Core Biopsy Instrument/ Disposable Coaxial Biopsy Needle

FDA 510(k) clearance K241793 · decided 2025-01-24

Clearance details

K-number
K241793
Device name
Automatic Core Biopsy Instrument/ Semi-Automatic Core Biopsy Instrument/ Disposable Coaxial Biopsy Needle
Applicant
Zhejiang Curaway Medical Technology Co., Ltd.
Decision
Substantially Equivalent
Date received
2024-06-21
Decision date
2025-01-24
Days to decision
217 days
Clearance type
Traditional
Product code
KNW
Device class
2
Regulation number
876.1075
Medical specialty
Gastroenterology, Urology
Advisory committee
Gastroenterology, Urology
Location
Hangzhou, CN
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.