Areus(TM) Adapt Endoscopic Ultrasound Aspiration Needle, Tridemt(TM) Endoscopic Ultrasound Aspiration Needle— 510(k) K212852

Substantially Equivalent

Micro-Tech (Nanjing) Co., Ltd.

FDA 510(k) clearance K212852 for Areus(TM) Adapt Endoscopic Ultrasound Aspiration Needle, Tridemt(TM) Endoscopic Ultrasound Aspiration Needle, Substantially Equivalent on 2021-12-06. Applicant: Micro-Tech (Nanjing) Co., Ltd..

Clearance details

Applicant: Micro-Tech (Nanjing) Co., Ltd.
Product code: Code ODG
Advisory panel: Gastroenterology, Urology
Date received: 2021-09-07
Decision date: 2021-12-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Nanjing, CN

Download summary PDF View on FDA.gov ↗

Adverse events under product code ODG

product code ODG

Death: 30
Injury: 237
Malfunction: 12,387
Other: 1
Total: 12,655

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.