EZDilate 3-Stage Balloon Dilatation Catheter
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K180086 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 EZDilate 3-Stage Balloon Dilatation Catheter is a wire-guided, dual-lumen catheter classified under Stents, Drains, and Dilators for the Biliary Ducts (product code FGE). It features a semi-compliant nylon balloon at the distal end, designed to mechanically widen strictures in the alimentary tract or the Sphincter of Oddi during endoscopic procedures. This device is engineered to provide controlled dilation across multiple stages, ensuring progressive and precise expansion of obstructed passages. Its dual-lumen design facilitates both guidewire compatibility and inflation/deflation functionality, enhancing procedural flexibility.
This catheter is intended for single-use in clinical settings such as gastroenterology and urology, where biliary or ductal strictures require dilation. Supplied sterile and packaged for one-time use, it adheres to Class II regulatory standards under FDA 510(k) clearance (K180086) and is intended for use in non-MRI environments. Available in standardized sizes (exact dimensions not specified in data), it requires proper storage to maintain sterility and functionality. No additional regulatory approvals beyond the stated 510(k) clearance are referenced in the provided data.
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: Gyrus ACMI - EZDilate 3-Stage Balloon Dilatation Catheter (K143609 ..., Gyrus ACMI - EZDilate 3-Stage Balloon Dilatation Catheter, K180086 - Gyrus ACMI - EZDilate 3-Stage Balloon D..., PDF Gyrus Medical Solid Organ Resection Device (SORD)
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K180086 | Class II | Active |
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Manufacturer
- Manufacturer
- Gyrus Acmi, Inc.
Sources (1)
- FDA 510(k) K180086 24 fields · synced Oct 6, 2026