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FDA 510(k)

Model 121 Biopsy Needle, Model 111 Biopsy Needle, Model 112 Biopsy Needle, and Model 131 Disposable Coaxial Biopsy Needle

K-Number: K214063 · 2022-06-03

ApplicantGuangzhou Shengwei Medical Devices Co., Ltd.
Decision Date2022-06-03
Product CodeKNW
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Model 121 Biopsy Needle, Model 111 Biopsy Needle, Model 112 Biopsy Needle, and Model 131 Disposable Coaxial Biopsy Needle is a medical device manufactured by Guangzhou Shengwei Medical Devices Co., Ltd.. It received FDA 510(k) clearance on 2022-06-03 under approval number K214063. 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 Model 121 Biopsy Needle, Model 111 Biopsy Needle, Model 112 Biopsy Needle, and Model 131 Disposable Coaxial Biopsy Needle?

Model 121 Biopsy Needle, Model 111 Biopsy Needle, Model 112 Biopsy Needle, and Model 131 Disposable Coaxial Biopsy Needle is a medical device that received FDA 510(k) clearance on 2022-06-03. It is manufactured by Guangzhou Shengwei Medical Devices Co., Ltd.. The 510(k) number is K214063.

When was Model 121 Biopsy Needle, Model 111 Biopsy Needle, Model 112 Biopsy Needle, and Model 131 Disposable Coaxial Biopsy Needle approved by the FDA?

Model 121 Biopsy Needle, Model 111 Biopsy Needle, Model 112 Biopsy Needle, and Model 131 Disposable Coaxial Biopsy Needle received FDA 510(k) clearance on 2022-06-03, under approval number K214063.

What company makes Model 121 Biopsy Needle, Model 111 Biopsy Needle, Model 112 Biopsy Needle, and Model 131 Disposable Coaxial Biopsy Needle?

Model 121 Biopsy Needle, Model 111 Biopsy Needle, Model 112 Biopsy Needle, and Model 131 Disposable Coaxial Biopsy Needle is manufactured by Guangzhou Shengwei Medical Devices Co., Ltd..

What is the FDA product code for Model 121 Biopsy Needle, Model 111 Biopsy Needle, Model 112 Biopsy Needle, and Model 131 Disposable Coaxial Biopsy Needle?

The FDA product code for Model 121 Biopsy Needle, Model 111 Biopsy Needle, Model 112 Biopsy Needle, and Model 131 Disposable Coaxial Biopsy Needle is KNW.

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Related Devices (Code: KNW)

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Official Source

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

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