Identifiers
- 510(k) Number
- K954619 FDA 510(k)
- FDA Product Code
- KNA FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 884.4530 FDA 510(k)
- Regulation Number
- 884.4530 FDA 510(k)
- Advisory Committee
- Obstetrics/Gynecology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Cordguard II is a specialized obstetric-gynecologic instrument designed as an umbilical clamp. It is intended for securing the umbilical cord during obstetric procedures to prevent bleeding and ensure proper cord management.
This device is supplied as a reusable instrument and is classified under FDA device class II. It was granted FDA 510(k) clearance under the product code KNA, with a decision date of December 21, 1995. The Cordguard II is regulated under the regulation number 884.4530 and is intended for use in obstetrics/gynecology settings.
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: Umbilical clamp - Cordguard™ - Utah Medical Products, CORDGUARD II (K954619) — FDA 510 (k) | Innolitics, Cordguard - Utah Medical Products - PDF Catalogs | Technical Documentation, Cordguard Ii 510 (k) FDA Premarket Notification K954619 UTAH MEDICAL ..., AccessGUDID - DEVICE: Cordguard® (H671CRD2010)
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K954619 | Class II | Active |
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Manufacturer
- Manufacturer
- Utah Medical Products, Inc.
Sources (1)
- FDA 510(k) K954619 24 fields · synced Oct 6, 2026