O'Neil Sterile Field Urinary Catheter Kit With Prep Pads
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K011055 FDA 510(k)
- FDA Product Code
- FCM FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 876.5130 FDA 510(k)
- Regulation Number
- 876.5130 FDA 510(k)
- Advisory Committee
- Gastroenterology, Urology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The O'Neil Sterile Field Urinary Catheter Kit is a sterile urethral catheterization tray designed for intermittent urinary catheterization. It features an introducer tip that bypasses organisms in the first 1.5cm of the distal urethra, reducing the risk of urinary tract infections. The kit includes prep pads and is designed as a closed system to protect the catheter from contamination by the operator.
The device is supplied as a single-use, sterile kit and is intended for use in urology and gastroenterology settings. It has FDA 510(k) clearance with K-number K011055 and is classified as Class II under product code FCM. The kit is manufactured by Go Medical Industries Pty. Ltd. and should be stored according to the manufacturer's instructions.
Frequently asked questions
What is the purpose of the O'Neil Sterile Field Urinary Catheter Kit?
The O'Neil Sterile Field Urinary Catheter Kit is designed for intermittent urinary catheterization. It features an introducer tip that bypasses organisms in the first 1.5cm of the distal urethra, reducing the risk of urinary tract infections.
How is the O'Neil Sterile Field Urinary Catheter Kit supplied?
The device is supplied as a single-use, sterile kit that includes prep pads. It is designed as a closed system to protect the catheter from contamination by the operator during use in urology and gastroenterology settings.
What is the regulatory status of the O'Neil Sterile Field Urinary Catheter Kit?
The kit has FDA 510(k) clearance with K-number K011055 and is classified as Class II under product code FCM. It received clearance on June 6, 2001, and is intended for use in urology and gastroenterology settings.
How should the O'Neil Sterile Field Urinary Catheter Kit be stored?
The kit should be stored according to the manufacturer's instructions to maintain its sterile integrity until use. As a single-use device, proper storage conditions are essential to ensure the sterility and effectiveness of the product.
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: Go Medical Industries Pty Ltd - O'Neil Urinary Catheter, The O'Neil Sterile Field Urinary Catheter Kit With Prep Pads, O Neil Sterile Field Urinary Intermittent Catheter Kit, The O'Neil Sterile Field Urinary Catheter Kit With Prep Pads
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K011055 | Class II | Active |
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Manufacturer
- Manufacturer
- Go Medical Industries Pty. Ltd.
- FDA Applicant
- Go Medical Industries Pty. , Ltd.
Sources (1)
- FDA 510(k) K011055 24 fields · synced Oct 1, 2026