Clearance Summary
Myriad Prostate Caddy¿ Immobilization Rectal Balloon Item #9901,3301 received FDA 510(k) clearance under submission number K150234, sponsored by Myriad Medical, LLC. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2015-03-31.
- Submission: K150234
- Applicant / Sponsor: Myriad Medical, LLC
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.5720
- Decision date: 2015-03-31
Classification & Regulation
This clearance is catalogued under FDA product code PCT and 21 CFR 892.5720, within the Radiology review panel as a Class II device.