Uresil Laparoscopic Cholangiography Catheter
FDA 510(k)Class II (US FDA 510(k))
by Uresil Corp.
Identifiers
- 510(k) Number
- K915343 FDA 510(k)
- FDA Product Code
- GCA 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 Laparoscopic Cholangiography Catheter is a biliary catheter designed for stone removal, irrigation, and contrast injection during laparoscopic procedures. According to the FDA classification, it falls under the category of biliary catheters intended for use in the biliary system, aiding in diagnostic and therapeutic interventions such as cholangiography and stone extraction.
This device is supplied as a single-use, non-sterile catheter and is intended for use in controlled clinical settings such as operating rooms or endoscopy suites. It is regulated under the FDA’s 510(k) clearance (K915343) and falls under device class II (regulation number 876.5010). The catheter is designed for laparoscopic procedures and must be sterilized prior to use, adhering to standard medical sterilization protocols. No MRI safety information is specified in the available data.
Frequently asked questions
What is the primary purpose of the Uresil Laparoscopic Cholangiography Catheter in a clinical setting?
The Uresil Laparoscopic Cholangiography Catheter is designed specifically for laparoscopic procedures to assist in stone removal, irrigation of the biliary system, and injection of contrast media for cholangiography. This dual functionality supports both diagnostic imaging and therapeutic interventions during surgery.
Is the Uresil Laparoscopic Cholangiography Catheter intended for single-use or can it be reused?
The device is explicitly labeled as a single-use catheter. While it is supplied in a non-sterile state, it must be sterilized prior to use according to standard medical protocols. Reuse is not recommended or supported by the manufacturer.
What medical specialties are most likely to use this catheter, and why?
The catheter is primarily intended for use in gastroenterology and urology specialties, as indicated by its FDA advisory committee classification (GU). This aligns with its role in biliary system interventions, including cholangiography and stone extraction, which are core procedures in these fields.
How should the catheter be stored before sterilization, and what are the key considerations?
The catheter is supplied in a non-sterile state, so it must be stored in a clean, dry environment away from direct sunlight or extreme temperatures until sterilization. Since it is designed for single-use and requires sterilization prior to use, proper packaging integrity and adherence to facility-specific sterilization protocols (e.g., autoclave or ethylene oxide) are critical to ensure safety and functionality.
What regulatory pathway was followed for FDA clearance of this device, and what does that mean for buyers?
The Uresil Laparoscopic Cholangiography Catheter received FDA 510(k) clearance (K915343) under the traditional review pathway, with a decision of *Substantially Equivalent* (SESE) to a predicate device. This means the FDA determined it has the same intended use and technological characteristics as a previously cleared biliary catheter, ensuring compliance with safety and effectiveness standards before market authorization.
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: 510(k) Premarket Notification, Uresil Corp. FDA 510 (k) Products (1981-2001), UreSil - Abscess Drainage Catheter, URESIL, LLC FDA Filings - FDA.report
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K915343 | Class II | Active |
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Manufacturer
- Manufacturer
- Uresil Corp.
Sources (1)
- FDA 510(k) K915343 24 fields · synced Sep 19, 2026