Bard Urodynamic Catheterization Procedure Tray
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K922527 FDA 510(k)
- FDA Product Code
- KOD 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
- SEKD FDA 510(k)
The Bard Urodynamic Catheterization Procedure Tray is a urological catheter designed for diagnostic and procedural use in urodynamic studies. It facilitates the assessment of bladder function, pressure measurements, and voiding dynamics by providing sterile components for catheter insertion and fluid management during evaluations.
This tray is intended for single-use in clinical settings such as urology offices, hospitals, or specialized diagnostic centers. Supplied sterile and packaged for one-time use, it includes necessary accessories for urodynamic testing, including catheters and connectors. The device complies with FDA 510(k) clearance (K922527) under product code KOD, classified as a Class II urological catheter under regulation 876.5130. No MRI safety information or reusable variants are specified.
Frequently asked questions
What is the Bard Urodynamic Catheterization Procedure Tray used for?
The Bard Urodynamic Catheterization Procedure Tray is designed for diagnostic and procedural use in urodynamic studies. It helps clinicians assess bladder function, measure pressure, and evaluate voiding dynamics during evaluations. This is particularly useful in urology offices, hospitals, or specialized diagnostic centers where detailed bladder assessments are required.
Is the tray intended for single-use or reusable applications?
The tray is explicitly intended for single-use only. It is supplied sterile and packaged to ensure contamination-free use in clinical settings. This design minimizes the risk of cross-contamination and maintains hygiene standards for diagnostic procedures.
What components are included in the tray?
The tray includes necessary sterile accessories for urodynamic testing, such as catheters and connectors. These components are specifically chosen to facilitate accurate pressure measurements and fluid management during bladder function assessments. The exact accessories may vary by model, but they are all designed for compatibility with urodynamic studies.
How should the tray be stored before use?
The tray should be stored in its original, unopened packaging to preserve sterility. It is recommended to keep it in a clean, dry environment away from direct sunlight or extreme temperatures. Always follow the manufacturer’s storage instructions to ensure the integrity of the components until use.
Does the tray have any specific regulatory approvals?
The tray holds FDA 510(k) clearance under product code KOD, classified as a Class II urological catheter. This clearance indicates that it meets regulatory standards for safety and effectiveness as determined by the FDA. Always refer to the device labeling for the most current regulatory information.
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: K922527 FDA 510(k) - BARD URODYNAMIC CATHETERIZATION PROCEDU..., BARD URODYNAMIC CATHETERIZATION PROCEDURE TRAY… - FDA.report, PDF K922527 - Bard Urodynamic Catheterization Procedure Tray
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K922527 | Class II | Active |
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Manufacturer
- Manufacturer
- C. R. Bard, Inc.
- FDA Applicant
- C.R. Bard, Inc.
Sources (1)
- FDA 510(k) K922527 24 fields · synced Oct 1, 2026