United States FDA 510(k) clearance K260516Substantially EquivalentBubbleView Single-Use Digital Flexible Cystoscope (C38-CS, C38-CRS, C50-C, C50-CR, C50-CB, C50-CBR)
- K-Number
- K260516
- Device Class
- Class 2
- Clearance Type
- Traditional
- Contact
- Ye Linbin
- Location
- 301, Bldg. 3, Namtai Inno Park In Guang Ming Ave.Shenzhen 518107CN
- Medical Specialty
- Gastroenterology, Urology
- Advisory Committee
- GU
- Date Received
- Feb 17, 2026
- Decision Date
- Jul 20, 2026
- Decision
- Substantially Equivalent
Summary
Access comprehensive regulatory information for BubbleView Single-Use Digital Flexible Cystoscope (C38-CS, C38-CRS, C50-C, C50-CR, C50-CB, C50-CBR) 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 K260516 and submitted by MacroLux Medical Technology Co., Ltd.. The clearance decision was Substantially Equivalent on Jul 20, 2026.
This page provides complete clearance details including product code FGB, 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.