United States FDA 510(k) clearance K250128Substantially EquivalentSingle Use Suction-Evacuation Ureteral Access Sheath
- K-Number
- K250128
- Device Class
- Class 2
- Clearance Type
- Traditional
- Contact
- Shuanghong Wang
- Location
- 5/F, Bldg. 4,Bengshan Science And Technology InnovationPark, 1600 YanAn S. Rd.Bengbu 233000CN
- Medical Specialty
- Gastroenterology, Urology
- Advisory Committee
- GU
- Date Received
- Jan 17, 2025
- Decision Date
- Sep 19, 2025
- Decision
- Substantially Equivalent
Summary
Access comprehensive regulatory information for Single Use Suction-Evacuation Ureteral Access Sheath 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 K250128 and submitted by Anhui Happiness Workshop Medical Instruments Co., Ltd.. The clearance decision was Substantially Equivalent on Sep 19, 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.