Tunneling Stylet
by Quinton, Inc. 510(k)
Active
510(k) K882097
Overview
The Tunneling Stylet is a catheter stylet designed to provide rigidity to a catheter or cannula during insertion. It functions as a dilator, facilitating the creation of a subcutaneous tunnel for positioning cuffed catheters, such as peritoneal dialysis catheters, by separating tissue while guiding the device.
This device is intended for single-use in clinical settings and is classified under FDA regulation number 870.1380 as a Class II medical device. Supplied sterile, it is regulated under the FDA 510(k) clearance (K882097) and falls under the Cardiovascular Device Advisory Committee for review. The product code DRB identifies its submission category, and it is not intended for reuse.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK882097 | Date28 Jul 1988 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- DRB
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.1380
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Other devices from Quinton, Inc.
Questions
What is the Quinton Tunneling Stylet used for?
The Tunneling Stylet is designed to provide rigidity to catheters or cannulas during insertion, acting as a dilator to create a subcutaneous tunnel. This facilitates the precise placement of cuffed catheters, such as peritoneal dialysis catheters, by separating tissue and guiding the device through the tunnel.
Is the Quinton Tunneling Stylet intended for reuse?
No, the Tunneling Stylet is explicitly intended for single-use only. This design ensures patient safety and sterility, as reuse could compromise the device’s integrity and introduce infection risks.
How is the Quinton Tunneling Stylet supplied?
The device is supplied sterile, ready for immediate clinical use. Sterility is maintained to prevent contamination during insertion, which is critical for procedures involving catheters in sensitive areas like peritoneal dialysis.
What regulatory pathway does the Quinton Tunneling Stylet follow?
The Tunneling Stylet is classified under FDA regulation number 870.1380 as a Class II medical device and has received FDA 510(k) clearance (K882097). It was reviewed by the Cardiovascular Device Advisory Committee, reflecting its role in procedures involving cardiovascular-related devices like catheters.
Are there different sizes or models of the Quinton Tunneling Stylet?
The provided data does not specify distinct sizes or models beyond the general description of a tunneling stylet for catheter insertion. However, the device is tailored for compatibility with cuffed catheters, particularly those used in peritoneal dialysis, ensuring proper tunneling and placement.