Oasis Biliary Stent Introduction System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K040151 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 Oasis Biliary Stent Introduction System is a sterile, single-use catheter system used by physicians during endoscopic procedures to facilitate the placement of biliary stents for the drainage of obstructed bile ducts. It functions as an introducer to guide and position the stent within the biliary tree.
The device is supplied sterile and intended for single-use only. It is used in endoscopic settings and has received FDA 510(k) clearance under K040151, with product code FGE and regulation number 876.5010, classified as a Class II device for biliary stent introduction.
Frequently asked questions
What is the Oasis Biliary Stent Introduction System used for?
The Oasis Biliary Stent Introduction System is used by physicians during endoscopic procedures to facilitate the placement of biliary stents for the drainage of obstructed bile ducts. It functions as an introducer to guide and position the stent within the biliary tree, enabling effective drainage when bile flow is blocked.
Is the Oasis Biliary Stent Introduction System sterile and single-use?
Yes, the device is supplied sterile and intended for single-use only. This ensures patient safety by eliminating the risk of cross-contamination and infection associated with reprocessing, and it is designed to be discarded after one endoscopic procedure.
What regulatory pathway was used for the Oasis Biliary Stent Introduction System?
The device received FDA 510(k) clearance under submission number K040151, with product code FGE and regulation number 876.5010. It was classified as a Class II device and found substantially equivalent to a predicate device, allowing it to be marketed for biliary stent introduction.
Who manufactures the Oasis Biliary Stent Introduction System and where is it located?
The Oasis Biliary Stent Introduction System is manufactured by Wilson-Cook Medical, Inc., located at 4900 Bethania Station Rd., Winston-Salem, NC 27105, United States. The manufacturer’s information is registered in the FDA’s device database under the provided address and FEI numbers.
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: OASIS BILIARY STENT INTRODUCTION SYSTEM (K040151) — FDA 510 (k ..., OASIS One Action Stent Introduction System® | Cook Medical, OASIS One Action Stent Introduction System® Preloaded with Cotton-Leung ..., OASIS One Action Stent Introduction System® - Cook Medical
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K040151 | Class II | Active |
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Manufacturer
- Manufacturer
- Wilson-Cook Medical, Inc.
Sources (1)
- FDA 510(k) K040151 24 fields · synced Oct 6, 2026