Identifiers
- 510(k) Number
- K770814 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
- SESE Substantially Equivalent FDA 510(k)
The Urethral Catheter is a urological device designed for insertion into the urethra to facilitate drainage. It is constructed from red latex to provide increased firmness compared to standard latex materials.
This device is available in multiple sizes ranging from 8 to 26 Fr and features various tip configurations, including straight and coude options. It is intended for use in urological settings and is regulated under the gastroenterology and urology advisory committee.
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: Bard® All-Purpose Red Rubber Unisex, 14FR, Straight, CR Bard PVC Urethral Catheters | Medline Industries, Inc., CR BARD - 010116, 524 - URETHRAL CATH 16FR COUDE TIP - Clock Medical Supply
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K770814 | Class II | Active |
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Manufacturer
- Manufacturer
- C. R. Bard, Inc.
- FDA Applicant
- C.R. Bard, Inc.
Sources (1)
- FDA 510(k) K770814 24 fields · synced Sep 24, 2026