Class Class II

Automatic Core Biopsy Instrument/ Semi-Automatic Core Biopsy Instrument/ Disposable Coaxial Biopsy Needle (K241793)

K241793 2025-01-24 Traditional
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Description

Automatic Core Biopsy Instrument/ Semi-Automatic Core Biopsy Instrument/ Disposable Coaxial 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) NumberK241793
Clearance Date2025-01-24
Clearance TypeTraditional
Product CodeKNW
Regulation Number876.1075

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Predicate lineage for K241793

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. Automatic Core Biopsy Instrument/ Semi-Automatic Core Biopsy Instrument/ Disposable Coaxial Biopsy Needle (K241793) cites 3 predicate devices and is itself cited by 0 later devices.

Predicate devices cited by this clearance

Devices this clearance was compared against
K numberDeviceApplicantYear
K171953Bard Mission Disposable Core Biopsy InstrumentBard Peripheral Vascular, Inc.2017
K141552ACHIEVE PROGRAMMABLE AUOMATED BIOPSY SYSTEMSCare Fusion2014
K133948BARD(R) MONOPTY(R) DISPOSABLE CORE BIOPSY INSTRUMENT, BARD(...Bard Peripheral Vascular, Inc.2014

Trace the full predicate network for K241793

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.

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