Clearance Summary
Cryotop®US-flash and Cryotop®US-scoop received FDA 510(k) clearance under submission number K181469, sponsored by Kitazato Corporation. The device was reviewed via the Traditional premarket notification pathway and assigned to the Obstetrics/Gynecology review panel. The statutory decision date of record is 2018-11-09.
- Submission: K181469
- Applicant / Sponsor: Kitazato Corporation
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.6160
- Decision date: 2018-11-09
Classification & Regulation
This clearance is catalogued under FDA product code MQK and 21 CFR 884.6160, within the Obstetrics/Gynecology review panel as a Class II device.