Clearance Summary
Mic-Key* SF Over-the-Wire Stoma Measuring Device received FDA 510(k) clearance under submission number K173955, sponsored by Halyard Health, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 2018-01-26.
- Submission: K173955
- Applicant / Sponsor: Halyard Health, Inc.
- Clearance pathway: Special
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5980
- Decision date: 2018-01-26
Classification & Regulation
This clearance is catalogued under FDA product code KNT and 21 CFR 876.5980, within the Gastroenterology, Urology review panel as a Class II device.