Metal Tipped Ureter. Stent & Magnetic Stent Retri.
by Surgitek
510(k) K863492
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK863492 | Date18 Dec 1986 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- FAD
- Device Class
- Class II
- Regulation
- 21 CFR Part 876.4620
- Advisory Committee
- Gastroenterology, Urology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
This device is a ureteral stent designed for temporary urinary drainage, featuring a metal-tipped design to facilitate placement within the ureter. It also includes a magnetic component for retrieval purposes, enabling removal after use. The stent helps relieve obstruction and supports urinary flow in clinical settings such as post-surgery or during diagnostic procedures.
The Metal-Tipped Ureteral Stent and Magnetic Stent Retriever is intended for single-use in sterile conditions, typically within urological or gastroenterological settings. It is classified as a Class II device under FDA regulation 876.4620 and received a Substantially Equivalent (SE) clearance via 510(k) pathway (K863492). Multiple sizes are available, as indicated by the listed registration numbers, and the device must be handled and stored according to manufacturer guidelines to maintain sterility and functionality.