Uresil Fixation Device
FDA 510(k)Class II (US FDA 510(k))
by Uresil Corp.
Identifiers
- 510(k) Number
- K914699 FDA 510(k)
- FDA Product Code
- FGE FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 876.5010 FDA 510(k)
- Regulation Number
- 876.5010 FDA 510(k)
- Advisory Committee
- Gastroenterology, Urology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Uresil Fixation Device is a stent, drain, or dilator for the biliary ducts, classified as a Class II medical device. It is designed to secure drainage catheters in place without crimping or kinking the catheter shaft by applying equal 360º pressure via a locking ring. The device includes a transparent dressing that allows visual observation of skin condition and can be changed without disturbing the wound site or dislodging the catheter. Replacement adhesive patches are sold separately.
The device is supplied as part of the Tru-Fix Catheter Fixation System by Uresil Corp., located at 5418 W. Touhy Ave., Skokie, IL 60077. It received FDA 510(k) clearance (K914699) on February 19, 1992, as substantially equivalent to a predicate device, under the review of the Gastroenterology and Urology advisory committee. The device is intended for use in minimally invasive procedures to secure drainage catheters, and its authorization is based on the product code FGE and regulation number 876.5010.
Frequently asked questions
What is the Uresil Fixation Device used for?
The Uresil Fixation Device is designed to secure drainage catheters in place within the biliary ducts without crimping or kinking the catheter shaft by applying equal 360º pressure via a locking ring, ensuring stable positioning during drainage procedures.
How is the Uresil Fixation Device supplied and what components does it include?
The device is supplied as part of the Tru-Fix Catheter Fixation System and includes a transparent dressing that allows visual observation of skin condition and can be changed without disturbing the wound site or dislodging the catheter; replacement adhesive patches are sold separately.
Is the Uresil Fixation Device intended for single-use or reuse?
While the device data does not explicitly state single-use or reuse, the inclusion of separately sold replacement adhesive patches and the ability to change the transparent dressing without disturbing the wound site suggest that certain components may be replaced, but the fixation device itself is likely intended for durable use during catheter indwelling as part of a fixation system.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Uresil - Catheter Fixation Device, Tru-Fix Catheter Fixation System by Uresil, TRU-FIX Catheter Fixation Device - Medline, Uresil Tru-Fix Catheter Fixation System - aidinstruments.com
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K914699 | Class II | Active |
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Manufacturer
- Manufacturer
- Uresil Corp.
Sources (1)
- FDA 510(k) K914699 24 fields · synced Sep 22, 2026