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FDA 510(k)

Areus(TM) Adapt Endoscopic Ultrasound Aspiration Needle, Tridemt(TM) Endoscopic Ultrasound Aspiration Needle

K-Number: K212852 · 2021-12-06

ApplicantMicro-Tech (Nanjing) Co., Ltd.
Decision Date2021-12-06
Product CodeODG
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Areus(TM) Adapt Endoscopic Ultrasound Aspiration Needle, Tridemt(TM) Endoscopic Ultrasound Aspiration Needle is a medical device manufactured by Micro-Tech (Nanjing) Co., Ltd.. It received FDA 510(k) clearance on 2021-12-06 under approval number K212852. The device is classified under product code ODG. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Areus(TM) Adapt Endoscopic Ultrasound Aspiration Needle, Tridemt(TM) Endoscopic Ultrasound Aspiration Needle?

Areus(TM) Adapt Endoscopic Ultrasound Aspiration Needle, Tridemt(TM) Endoscopic Ultrasound Aspiration Needle is a medical device that received FDA 510(k) clearance on 2021-12-06. It is manufactured by Micro-Tech (Nanjing) Co., Ltd.. The 510(k) number is K212852.

When was Areus(TM) Adapt Endoscopic Ultrasound Aspiration Needle, Tridemt(TM) Endoscopic Ultrasound Aspiration Needle approved by the FDA?

Areus(TM) Adapt Endoscopic Ultrasound Aspiration Needle, Tridemt(TM) Endoscopic Ultrasound Aspiration Needle received FDA 510(k) clearance on 2021-12-06, under approval number K212852.

What company makes Areus(TM) Adapt Endoscopic Ultrasound Aspiration Needle, Tridemt(TM) Endoscopic Ultrasound Aspiration Needle?

Areus(TM) Adapt Endoscopic Ultrasound Aspiration Needle, Tridemt(TM) Endoscopic Ultrasound Aspiration Needle is manufactured by Micro-Tech (Nanjing) Co., Ltd..

What is the FDA product code for Areus(TM) Adapt Endoscopic Ultrasound Aspiration Needle, Tridemt(TM) Endoscopic Ultrasound Aspiration Needle?

The FDA product code for Areus(TM) Adapt Endoscopic Ultrasound Aspiration Needle, Tridemt(TM) Endoscopic Ultrasound Aspiration Needle is ODG.

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

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Related Devices (Code: ODG)

K160845Acquire Endoscopic Ultrasound Fine Needle Biopsy (FNB) DeviceBoston Scientific Corporation K173184Expect Slimline (SL) Endoscopic Ultrasound Aspiration NeedleBoston Scientific K172309Endoscopic Ultrasound Aspiration NeedleMicro-Tech (Nanjing) Co., Ltd. K162447PENTAX Medical Endoscopic Ultrasound System, EG-3270UK Upper G.I. Video Scope (Convex Array Type) with EPK-i5010 Video Processor and HI VISION Preirus Ultrasound ScannerPentax of America, Inc. K163058Expect Slimline (SL) Endoscopic Ultrasound Aspiration NeedleBoston Scientific K182004PENTAX Medical Endoscopic Ultrasound SystemPentax of America, 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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