Clearance Summary
RectalPro 75 Endorectal Balloon received FDA 510(k) clearance under submission number K180478, sponsored by Qlrad International , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2018-11-13.
- Submission: K180478
- Applicant / Sponsor: Qlrad International , Ltd.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.5720
- Decision date: 2018-11-13
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.