United States FDA 510(k) clearance K242765Substantially EquivalentElectronic Apex Locator (Alpha Apex I)
United StatesClass USHENZHEN SUPERLINE TECHNOLOGY CO., LTD.Cleared Jan 17, 2025
Clearance details
- K-Number
- K242765
- Device Class
- Class U
- Clearance Type
- Traditional
Note: PDF may not be available for all submissions
Applicant information
- Contact
- Jinsong Zhou
- Location
- Rm. 302, Nanshan Zhiyuan A4, #1001 Xueyuan Ave.,Changyuan Community, Taoyuan St., Nanshan DistrictShenzhen 518000CN
Medical classification
- Medical Specialty
- Unknown
Dates and decision
- Date Received
- Sep 13, 2024
- Decision Date
- Jan 17, 2025
- Decision
- Substantially Equivalent
Statement / Summary
Summary
About this record
Access comprehensive regulatory information for Electronic Apex Locator (Alpha Apex I) in the USA medical device market through Pure Global AI's free database. This Class U medical device was cleared under FDA 510(k) number K242765 and submitted by SHENZHEN SUPERLINE TECHNOLOGY CO., LTD.. The clearance decision was Substantially Equivalent on Jan 17, 2025.
This page provides complete clearance details including product code LQY, medical specialty classification (Unknown), and regulatory compliance information from the official FDA OpenFDA database. Pure Global AI offers free access to FDA 510(k) clearances from 1976 to present, helping global MedTech companies navigate USA FDA regulations efficiently.