United States FDA 510(k) clearance K250452Substantially EquivalentCoralWell Single-use Ureteral Access Sheath (NS-0835B, NS-0840B, NS-0845B, NS-0855B, NS-0935B, NS-0940B, NS-0945B, NS-0955B, NS-1035B, NS-1040B, NS-1045B, NS-1055B, NS-1135B, NS-1140B, NS-1145B, NS-1155B, NS-1235B, NS-1240B, NS-1245B, NS-1255B, NS-1335B, NS-1340B, NS-1345B, NS-1355B, NS-1435B, NS-1440B, NS-1445B, NS-1455B)
- K-Number
- K250452
- Device Class
- Class 2
- Clearance Type
- Traditional
- Contact
- Ye Linbin
- Location
- 301, Bldg. 3, Namtai Inno Park In Guang Ming Ave.GuangmingShenzhen 518107CN
- Medical Specialty
- Gastroenterology, Urology
- Advisory Committee
- GU
- Date Received
- Feb 18, 2025
- Decision Date
- Jun 02, 2025
- Decision
- Substantially Equivalent
Statement
Access comprehensive regulatory information for CoralWell Single-use Ureteral Access Sheath (NS-0835B, NS-0840B, NS-0845B, NS-0855B, NS-0935B, NS-0940B, NS-0945B, NS-0955B, NS-1035B, NS-1040B, NS-1045B, NS-1055B, NS-1135B, NS-1140B, NS-1145B, NS-1155B, NS-1235B, NS-1240B, NS-1245B, NS-1255B, NS-1335B, NS-1340B, NS-1345B, NS-1355B, NS-1435B, NS-1440B, NS-1445B, NS-1455B) 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 K250452 and submitted by MacroLux Medical Technology Co., Ltd.. The clearance decision was Substantially Equivalent on Jun 02, 2025.
This page provides complete clearance details including product code FED, 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.