Clearance Summary
Mercy babyTAPE received FDA 510(k) clearance under submission number K191174, sponsored by Children'S Mercy Hospital. 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 2019-10-10.
- Submission: K191174
- Applicant / Sponsor: Children'S Mercy Hospital
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4800
- Decision date: 2019-10-10
Classification & Regulation
This clearance is catalogued under FDA product code PIR and 21 CFR 878.4800, within the General, Plastic Surgery review panel as a Class I device.