Clearance Summary
CRYOTOP received FDA 510(k) clearance under submission number K112695, sponsored by Kitazato Biopharma Co;Ltd. 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 2012-12-12.
- Submission: K112695
- Applicant / Sponsor: Kitazato Biopharma Co;Ltd
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.6160
- Decision date: 2012-12-12
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.