FDA 510(k) Search

K Number

K243296

Device Name

Disposable Biopsy Needle

Manufacturer

Carbon (Shenzhen) Medical Device Co., Ltd.

Date Cleared

2025-07-11

Product Code

KNW

Regulation Number

876.1075

Intended Use

PDF not available yet

Device Description

PDF not available yet

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

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Class Advise Committee

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Third Party Reviewed

Expedited Review

AI/ML (Artificial Intelligence / Machine Learning)

null

Therapeutic

null

Diagnostic

null

SaMD (Software as a Medical Device)

null

IVD (In Vitro Diagnostic)

null

PCCP (Predetermined Change Control Plan) Authorized

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Overview

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Summary

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