Cleared Traditional

AreusTM Endobronchial Ultrasound Aspiration Needle, TridentTM Endobronchial Ultrasound Aspiration Needle

K213060 · Micro-Tech (Nanjing) Co., Ltd. · Anesthesiology

Jul 2022

Decision

301d

Days

Class 2

Risk

About This 510(k) Submission

K213060 is an FDA 510(k) clearance for the AreusTM Endobronchial Ultrasound Aspiration Needle, TridentTM Endobronchial Ultrasound Aspiration Needle, a Bronchoscope Accessory (Class II — Special Controls, product code KTI), submitted by Micro-Tech (Nanjing) Co., Ltd. (Nanjing, CN). The FDA issued a Cleared decision on July 20, 2022, 301 days after receiving the submission on September 22, 2021. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 874.4680.

Submission Details

510(k) Number	K213060 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 22, 2021
Decision Date	July 20, 2022
Days to Decision	301 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Summary PDF

Device Classification

Product Code	KTI — Bronchoscope Accessory
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 874.4680
Definition	If The Device Is Reusable, Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission (82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).