Disposable Blood Lancets— 510(k) K220387

Substantially Equivalent

Suzhou Kyuan Medical Apparatus Co., Ltd.

FDA 510(k) clearance K220387 for Disposable Blood Lancets, Substantially Equivalent on 2022-08-17. Applicant: Suzhou Kyuan Medical Apparatus Co., Ltd..

Clearance details

Applicant: Suzhou Kyuan Medical Apparatus Co., Ltd.
Product code: Code QRL
Advisory panel: General, Plastic Surgery
Date received: 2022-02-10
Decision date: 2022-08-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Suzhou, CN

Download summary PDF View on FDA.gov ↗

Adverse events under product code QRL

product code QRL

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.