Clearance Summary
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 received FDA 510(k) clearance under submission number K222168, sponsored by Owen Mumford, Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 2022-11-03.
- Submission: K222168
- Applicant / Sponsor: Owen Mumford, Ltd.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4850
- Decision date: 2022-11-03
Classification & Regulation
This clearance is catalogued under FDA product code FMK and 21 CFR 878.4850, within the General, Plastic Surgery review panel as a Class II device.