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Mi-eye 3 Needlescope With Cannula, Mi-tablet 3

FDA 510(k)

Class II (US FDA 510(k))

510(k) K212556

by Trice Medical, Inc.

Identifiers

510(k) Number
K212556 FDA 510(k)
FDA Product Code
HRX FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 888.1100 FDA 510(k)
Regulation Number
888.1100 FDA 510(k)
Advisory Committee
Orthopedic FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The mi-eye 3 needlescope with cannula and mi-tablet 3 is an orthopedic imaging system designed for diagnostic and operative arthroscopic and endoscopic procedures. It provides illumination and visualization of an interior cavity of the body through either a natural or surgical opening.

This single-use needlescope is paired with the mi-tablet 3 for portable visualization. The device is FDA 510(k) cleared for use in clinical settings. It is identified under product code HRX and is subject to the regulatory requirements associated with its clearance.

Frequently asked questions

What is the primary function of the mi-eye 3 needlescope system?

The mi-eye 3 needlescope with cannula and mi-tablet 3 is an orthopedic imaging system. It is designed to provide illumination and visualization of the interior cavities of the body, facilitating both diagnostic and operative arthroscopic and endoscopic procedures.

Is the mi-eye 3 needlescope intended for single-use or multiple uses?

The mi-eye 3 needlescope is a single-use device. This design ensures that each procedure is performed with a sterile, new instrument, reducing the risks associated with reprocessing and cross-contamination.

What is the regulatory status of the mi-eye 3 needlescope system?

The mi-eye 3 needlescope with cannula and mi-tablet 3 is FDA 510(k) cleared. It is identified under product code HRX and is subject to the regulatory requirements associated with this clearance for use in clinical 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: mi-eye - Trice Medical, Patient-mi-eye - Trice Medical, mi-eye 3 needlescope with cannula, mi-tablet 3 (K212556) — FDA 510(k ..., mi-eye 3 Handheld Diagnostic Scope System - medical-xprt.com

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Trice Medical, Inc.

Sources (1)

  • FDA 510(k) K212556 24 fields · synced Oct 6, 2026