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FDA 510(k)

Disposable Biopsy Needle

K-Number: K243296 · 2025-07-11

ApplicantCarbon (Shenzhen) Medical Device Co., Ltd.
Decision Date2025-07-11
Product CodeKNW
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Disposable Biopsy Needle is a medical device manufactured by Carbon (Shenzhen) Medical Device Co., Ltd.. It received FDA 510(k) clearance on 2025-07-11 under approval number K243296. The device is classified under product code KNW. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Disposable Biopsy Needle?

Disposable Biopsy Needle is a medical device that received FDA 510(k) clearance on 2025-07-11. It is manufactured by Carbon (Shenzhen) Medical Device Co., Ltd.. The 510(k) number is K243296.

When was Disposable Biopsy Needle approved by the FDA?

Disposable Biopsy Needle received FDA 510(k) clearance on 2025-07-11, under approval number K243296.

What company makes Disposable Biopsy Needle?

Disposable Biopsy Needle is manufactured by Carbon (Shenzhen) Medical Device Co., Ltd..

What is the FDA product code for Disposable Biopsy Needle?

The FDA product code for Disposable Biopsy Needle is KNW.

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Other Devices by Carbon (Shenzhen) Medical Device Co., Ltd.

K243298Venus Ultimate-Dual, Venus Ultimate-Hepa, Venus Ultimate-Uro Diagnostic Ultrasound System

Related Devices (Code: KNW)

K160316SemiCut Semi-automatic Biopsy Needle, Themy Automatic Disposable Biopsy Device, Palium Automatic Reusable Biopsy Device, EasyCut Semi-automatic Biopsy Needle, MDL Biopsy and Coaxial Introducer NeedlesM.D.L. S.R.L. K153709Mammotome elite Biopsy System-13G Probe, Mammotome elite Biopsy System-10G Probe, Mammotome elite Biopsy System-Holster, Mammotome elite Biopsy System-13G Introducer Stylet, Mammotome elite Biopsy System-10G Introducer StyletDevicor Medical Products, Inc. K161234CASSI II Rotational Core Biopsy SystemScion Medical Technologies, LLC K161409M-Biopsy Semi-Automatic Biopsy Instrument M-Biopsy Coaxial Introducer Needle for SemMermaid Medical A/S K161805EnCor MRI Introducer Set, EnCor Probe IntroducerSenorx, Inc. K153337Corvocet Biopsy SystemMerit Medical Systems, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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