Identifiers
- 510(k) Number
- K873569 FDA 510(k)
- FDA Product Code
- FMI FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 880.5570 FDA 510(k)
- Regulation Number
- 880.5570 FDA 510(k)
- Advisory Committee
- General Hospital FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Blood Needle Holder is a medical device designed to facilitate the secure handling of needles during blood-related procedures. It serves as a support tool for clinical staff to maintain control and stability when managing needles in a hospital setting.
This device is supplied by Sage Products, Inc. and has received FDA 510(k) clearance. It is categorized under product code FMI for use within general hospital environments.
Frequently asked questions
What is the primary purpose of the Blood Needle Holder?
The Blood Needle Holder is designed to assist clinical staff in maintaining control and stability when managing needles during blood-related procedures in a hospital setting.
Who is the manufacturer of this device?
This device is manufactured by Sage Products, Inc., located in Cary, Illinois.
What is the regulatory status of the Blood Needle Holder?
The Blood Needle Holder has received FDA 510(k) clearance, which indicates that the device has been determined to be substantially equivalent to a legally marketed predicate device.
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: K873569 FDA 510(k) - BLOOD NEEDLE HOLDER | Sage Products, Inc., BLOOD NEEDLE HOLDER (K873569) — FDA 510(k) | Innolitics, Blood Needle Holder 510 (k) FDA Premarket Notification K873569 SAGE ..., Blood | Definition, Composition, Functions, & Facts | Britannica, Sage Products - amazon.com
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K873569 | Class II | Active |
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Manufacturer
- Manufacturer
- Sage Products, Inc.
Sources (1)
- FDA 510(k) K873569 24 fields · synced Sep 23, 2026