Single Use Injection Needle— 510(k) K210917

Substantially Equivalent

Anrei Medical (Hangzhou) Co., Ltd.

FDA 510(k) clearance K210917 for Single Use Injection Needle, Substantially Equivalent on 2021-05-28. Applicant: Anrei Medical (Hangzhou) Co., Ltd..

Clearance details

Applicant: Anrei Medical (Hangzhou) Co., Ltd.
Product code: Code FBK
Advisory panel: Gastroenterology, Urology
Date received: 2021-03-29
Decision date: 2021-05-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hangzhou, CN

Download summary PDF View on FDA.gov ↗

Adverse events under product code FBK

product code FBK

Other: 1
Total: 1

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.