Needlesafe II & Needlegard II
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K936235 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)
Needlesafe II & Needlegard II is a medical safety device that enables single-handed recapping of needles, I.V. catheters and phlebotomy sets. It can be mounted horizontally or vertically to provide protection whenever and wherever needed.
The device is manufactured by Ingenious Technologies Corp. and has FDA 510(k) clearance with product code FMI. It is supplied as a safety device for use in healthcare settings, though specific details regarding sterility, single-use or reusable status, MRI safety, and sizes are not provided in the data.
Frequently asked questions
What is the Needlesafe II & Needlegard II device used for?
The Needlesafe II & Needlegard II is a medical safety device designed to enable single-handed recapping of needles, I.V. catheters, and phlebotomy sets, providing protection in healthcare settings.
How is the Needlesafe II & Needlegard II device supplied?
The device is supplied as a safety device for use in healthcare settings, though specific details regarding sterility, single-use or reusable status, MRI safety, and available sizes are not provided in the data.
What is the regulatory status of the Needlesafe II & Needlegard II?
The Needlesafe II & Needlegard II has FDA 510(k) clearance with product code FMI, manufactured by Ingenious Technologies Corp. It was cleared on March 28, 1994, and is substantially equivalent to other devices in its class.
How can the Needlesafe II & Needlegard II be installed?
The device can be mounted either horizontally or vertically, providing flexibility in placement to ensure protection whenever and wherever it is needed in a healthcare environment.
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: NEEDLESAFE II & NEEDLEGARD II (K936235) — FDA 510 (k) | Innolitics, NEEDLESAFE II & NEEDLEGARD II 510 (k) K936235 - FDA.report, Ingenious Technologies Corp FDA Filings, INGENIOUS TECHNOLOGIES CORPORATION II NeedleSafe - RevMed, NEEDLESAFE II & NEEDLEGARD II (K936235) — FDA 510 (k) | Innolitics
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K936235 | Class II | Active |
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Manufacturer
- Manufacturer
- Ingenious Technologies Corp.
Sources (1)
- FDA 510(k) K936235 24 fields · synced Sep 22, 2026