United States FDA 510(k) clearance K240283Substantially EquivalentBubbleView Single-Use Digital Flexible Cystoscope (C50-C, C50-CR, C50-CB, C50-CBR); ViewHub® Video Processor (S13, S13-T, S13-N, S13-S)
- K-Number
- K240283
- Device Class
- Class 2
- Clearance Type
- Traditional
- Contact
- Linbin Ye
- Location
- 301, Bldg. 3, Namtai Inno Park In Guang Ming Ave.GuangmingShenzhenCN
- Medical Specialty
- Gastroenterology, Urology
- Advisory Committee
- GU
- Date Received
- Feb 01, 2024
- Decision Date
- Jun 10, 2024
- Decision
- Substantially Equivalent
Summary
Access comprehensive regulatory information for BubbleView Single-Use Digital Flexible Cystoscope (C50-C, C50-CR, C50-CB, C50-CBR); ViewHub® Video Processor (S13, S13-T, S13-N, S13-S) in the USA medical device market through Pure Global AI's free database. This Class 2 medical device was cleared under FDA 510(k) number K240283 and submitted by MacroLux Medical Technology Co., Ltd.. The clearance decision was Substantially Equivalent on Jun 10, 2024.
This page provides complete clearance details including product code FAJ, medical specialty classification (Gastroenterology, Urology), 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.