Unistik® 3 Single-Use Safety Lancets:- Extra (21G), Normal (23G), Comfort (28G), Gentle (30G)— 510(k) K231124

Substantially Equivalent

Owen Mumford, Ltd.

FDA 510(k) clearance K231124 for Unistik® 3 Single-Use Safety Lancets:- Extra (21G), Normal (23G), Comfort (28G), Gentle (30G), Substantially Equivalent on 2023-06-27. Applicant: Owen Mumford, Ltd..

Clearance details

Applicant: Owen Mumford, Ltd.
Product code: Code FMK
Advisory panel: General, Plastic Surgery
Date received: 2023-04-20
Decision date: 2023-06-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Woodstock, GB

Download summary PDF View on FDA.gov ↗

Adverse events under product code FMK

product code FMK

Injury: 133
Malfunction: 1,278
Other: 1
Total: 1,412

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.