Unistik TinyTouch Sterile Single-Use Heel Incision Safety Lancets - Preemie and Full-Term, Unistik Heelstik Sterile Single-Use Heel Incision Safety Lancets - MicroPreemie, Preemie, Full-Term and Toddler— 510(k) K222168

Substantially Equivalent

Owen Mumford, Ltd.

FDA 510(k) clearance K222168 for Unistik TinyTouch Sterile Single-Use Heel Incision Safety Lancets - Preemie and Full-Term, Unistik Heelstik Sterile Single-Use Heel Incision Safety Lancets - MicroPreemie, Preemie, Full-Term and Toddler, Substantially Equivalent on 2022-11-03. Applicant: Owen Mumford, Ltd..

Clearance details

Applicant: Owen Mumford, Ltd.
Product code: Code FMK
Advisory panel: General, Plastic Surgery
Date received: 2022-07-21
Decision date: 2022-11-03
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.