AreusTM Endobronchial Ultrasound Aspiration Needle, TridentTM Endobronchial Ultrasound Aspiration Needle— 510(k) K213060

Name: FDA 510(k) clearance K213060
Creator: U.S. Food and Drug Administration
Published: 2022-07-20

Substantially Equivalent

Micro-Tech (Nanjing) Co., Ltd.

FDA 510(k) clearance K213060 for AreusTM Endobronchial Ultrasound Aspiration Needle, TridentTM Endobronchial Ultrasound Aspiration Needle, Substantially Equivalent on 2022-07-20. Applicant: Micro-Tech (Nanjing) Co., Ltd.. Device class: 2.

Clearance details

Applicant: Micro-Tech (Nanjing) Co., Ltd.
Product code: Code KTI
Device class: Class 2
Regulation: 21 CFR 874.4680
Advisory panel: Ear, Nose, Throat
Date received: 2021-09-22
Decision date: 2022-07-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Nanjing, CN

Download summary PDF View on FDA.gov ↗

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Adverse events under product code KTI

product code KTI

Malfunction: 642
Total: 642

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.