Clearance Summary
Klarity SRS Baseplate, Klarity Promise Baseplate received FDA 510(k) clearance under submission number K220539, sponsored by Klarity Medical & Equipment (GZ) Co., 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 2022-11-01.
- Submission: K220539
- Applicant / Sponsor: Klarity Medical & Equipment (GZ) Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.5050
- Decision date: 2022-11-01
Classification & Regulation
This clearance is catalogued under FDA product code IYE and 21 CFR 892.5050, within the Radiology review panel as a Class II device.