Clearance Summary
TD-5010 Lancing Device and TD-5084 Sterile Lancets received FDA 510(k) clearance under submission number K221419, sponsored by Gostar Co., 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 2023-01-20.
- Submission: K221419
- Applicant / Sponsor: Gostar Co., Ltd.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4850
- Decision date: 2023-01-20
Classification & Regulation
This clearance is catalogued under FDA product code QRL and 21 CFR 878.4850, within the General, Plastic Surgery review panel as a Class II device.