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Unifine SafeControl

FDA 510(k)

Class II (US FDA 510(k))

510(k) K210399

by Owen Mumford Ltd

Identifiers

510(k) Number
K210399 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)

Unifine SafeControl is a safety pen needle designed for use with injection pens to deliver medication doses while protecting healthcare professionals from needlestick injuries. It features a visible needle for precise control during injections using conventional pen needle technique and includes a manual push tab for one-handed activation of the safety mechanism.

The device is supplied sterile and intended for single-use. It is authorised under FDA 510(k) clearance (K210399) with product code FMI and was determined to be substantially equivalent to a predicate device. The device is used in general hospital settings for subcutaneous injections via pen injectors.

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: Unifine® SafeControl® | Owen Mumford, Unifine® SafeControl® | Owen Mumford, Home - Unifine SafeControl, Product - Unifine SafeControl

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Owen Mumford Ltd
FDA Applicant
Owen Mumford, Ltd.

Sources (1)

  • FDA 510(k) K210399 24 fields · synced Sep 22, 2026