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FDA 510(k)

AreusTM Endobronchial Ultrasound Aspiration Needle, TridentTM Endobronchial Ultrasound Aspiration Needle

K-Number: K213060 · 2022-07-20

ApplicantMicro-Tech (Nanjing) Co., Ltd.
Decision Date2022-07-20
Product CodeKTI
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

AreusTM Endobronchial Ultrasound Aspiration Needle, TridentTM Endobronchial Ultrasound Aspiration Needle is a medical device manufactured by Micro-Tech (Nanjing) Co., Ltd.. It received FDA 510(k) clearance on 2022-07-20 under approval number K213060. The device is classified under product code KTI. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AreusTM Endobronchial Ultrasound Aspiration Needle, TridentTM Endobronchial Ultrasound Aspiration Needle?

AreusTM Endobronchial Ultrasound Aspiration Needle, TridentTM Endobronchial Ultrasound Aspiration Needle is a medical device that received FDA 510(k) clearance on 2022-07-20. It is manufactured by Micro-Tech (Nanjing) Co., Ltd.. The 510(k) number is K213060.

When was AreusTM Endobronchial Ultrasound Aspiration Needle, TridentTM Endobronchial Ultrasound Aspiration Needle approved by the FDA?

AreusTM Endobronchial Ultrasound Aspiration Needle, TridentTM Endobronchial Ultrasound Aspiration Needle received FDA 510(k) clearance on 2022-07-20, under approval number K213060.

What company makes AreusTM Endobronchial Ultrasound Aspiration Needle, TridentTM Endobronchial Ultrasound Aspiration Needle?

AreusTM Endobronchial Ultrasound Aspiration Needle, TridentTM Endobronchial Ultrasound Aspiration Needle is manufactured by Micro-Tech (Nanjing) Co., Ltd..

What is the FDA product code for AreusTM Endobronchial Ultrasound Aspiration Needle, TridentTM Endobronchial Ultrasound Aspiration Needle?

The FDA product code for AreusTM Endobronchial Ultrasound Aspiration Needle, TridentTM Endobronchial Ultrasound Aspiration Needle is KTI.

Related Clinical Trials

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Other Devices by Micro-Tech (Nanjing) Co., Ltd.

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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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