Clearance Summary
Apex Locator received FDA 510(k) clearance under submission number K242383, sponsored by Shenzhen Rogin Medical Co., Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Unknown review panel. The statutory decision date of record is 2025-03-07.
- Submission: K242383
- Applicant / Sponsor: Shenzhen Rogin Medical Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Unknown
- Device class:
- Decision date: 2025-03-07
Classification & Regulation
This clearance is catalogued under FDA product code LQY , within the Unknown review panel as a device.