Clearance Summary
Ureteral Stent Open Tip/Closed Tip/Intraoperative Tip, Ureteral Stent via Ureterorenoscope Open Tip/Closed Tip, Pediatric Ureteral Stent Open Tip/Closed Tip, Mono J Urinary Diversion Ureteral Stent Open Tip/Closed Tip, Multiloop Ureteral Stent Open Tip/Closed Tip received FDA 510(k) clearance under submission number K190659, sponsored by Allwin Medical Devices, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 2019-12-02.
- Submission: K190659
- Applicant / Sponsor: Allwin Medical Devices, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.4620
- Decision date: 2019-12-02
Classification & Regulation
This clearance is catalogued under FDA product code FAD and 21 CFR 876.4620, within the Gastroenterology, Urology review panel as a Class II device.