Freestyle Lancing Device II, Autolet, Autolet Lite, Unilet Lancets— 510(k) K221613

Substantially Equivalent

Owen Mumford, Ltd.

FDA 510(k) clearance K221613 for Freestyle Lancing Device II, Autolet, Autolet Lite, Unilet Lancets, Substantially Equivalent on 2022-10-03. Applicant: Owen Mumford, Ltd..

Clearance details

Applicant: Owen Mumford, Ltd.
Product code: Code QRL
Advisory panel: General, Plastic Surgery
Date received: 2022-06-03
Decision date: 2022-10-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Woodstock, GB

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.