Multi-Lancet Device 2, ReliOn Premier Lancing Device— 510(k) K221175

Substantially Equivalent

Arkray, Inc.

FDA 510(k) clearance K221175 for Multi-Lancet Device 2, ReliOn Premier Lancing Device, Substantially Equivalent on 2022-10-17. Applicant: Arkray, Inc..

Clearance details

Applicant: Arkray, Inc.
Product code: Code QRL
Advisory panel: General, Plastic Surgery
Date received: 2022-04-25
Decision date: 2022-10-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kyoto, JP

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.