Clearance Summary
UROVANTAGE received FDA 510(k) clearance under submission number K053279, sponsored by Pck Electronic Industry & Trade Co., Ltd.. The device was reviewed via the Special premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2005-12-22.
- Submission: K053279
- Applicant / Sponsor: Pck Electronic Industry & Trade Co., Ltd.
- Clearance pathway: Special
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1650
- Decision date: 2005-12-22
Classification & Regulation
This clearance is catalogued under FDA product code OWB and 21 CFR 892.1650, within the Radiology review panel as a Class II device.