Unistik® ShieldLock, Unistik VacuFlip— 510(k) K223854

Substantially Equivalent

Owen Mumford, Ltd.

FDA 510(k) clearance K223854 for Unistik® ShieldLock, Unistik VacuFlip, Substantially Equivalent on 2023-06-30. Applicant: Owen Mumford, Ltd..

Clearance details

Applicant: Owen Mumford, Ltd.
Product code: Code JKA
Advisory panel: Clinical Chemistry
Date received: 2022-12-23
Decision date: 2023-06-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Woodstock, GB

Download summary PDF View on FDA.gov ↗

Adverse events under product code JKA

product code JKA

Injury: 455
Malfunction: 26,686
Other: 4
Total: 27,145

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.