Silicone Double Coil Ureteral Stent With Suture
by Mentor Corp. 510(k)
Active
510(k) K862539
Overview
The Silicone Double Coil Ureteral Stent With Suture is a medical device classified as a ureteral stent, designed to maintain ureteral patency and facilitate urine flow. Constructed from silicone, this stent features a double-coil design with embedded sutures to enhance stability and secure positioning within the ureter.
This device is intended for single-use implantation in a clinical setting and is supplied sterile. It is classified as a Class II medical device under FDA regulations (21 CFR 876.4620) and holds an FDA 510(k) clearance (K862539) for substantial equivalence. Multiple registration numbers (e.g., 2527072, 1123137) correspond to its distribution and regulatory filing. The device is not MRI-safe, and proper storage conditions must be maintained to preserve sterility.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK862539 | Date9 Sep 1986 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- 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
Other devices from Mentor Corp.
Questions
What is the primary purpose of the Silicone Double Coil Ureteral Stent With Suture, and how does its design support this function?
The Silicone Double Coil Ureteral Stent With Suture is designed to maintain ureteral patency and ensure smooth urine flow by keeping the ureter open. Its double-coil structure provides stability within the ureter, while the embedded sutures help secure its position, reducing the risk of migration or displacement during use.
Is this device intended for reuse, or is it meant to be used only once? How should it be handled to ensure safety?
This device is explicitly designed for single-use implantation in a clinical setting. Since it is supplied sterile, it must remain unopened and uncontaminated until use. After implantation, it should be discarded to prevent infection or complications from reuse.
Can this stent be used in patients who require MRI imaging, or are there any safety concerns related to magnetic fields?
The device is not MRI-safe, meaning it should not be used in patients who require MRI imaging. The silicone material and design do not guarantee compatibility with magnetic resonance imaging, which could pose risks to the patient or interfere with diagnostic accuracy.
How should the Silicone Double Coil Ureteral Stent With Suture be stored to maintain its sterility and integrity?
To preserve sterility and functionality, the device must be stored under controlled conditions as specified by the manufacturer. This typically includes protection from moisture, extreme temperatures, and physical damage. Always follow the included storage instructions to ensure the stent remains uncontaminated and ready for use.
What regulatory pathway was followed for this device’s approval, and which medical specialties are primarily involved in its use?
The device received FDA 510(k) clearance (K862539) under the Traditional pathway, demonstrating substantial equivalence to a predicate device. It is classified under 21 CFR 876.4620 as a Class II medical device. The primary medical specialties involved in its use are Gastroenterology and Urology, as indicated by the advisory committee and product-code category records.