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Gyrus Acmi Invisio Digital Hysteroscope, Model IDH-4

FDA 510(k)

Class II (US FDA 510(k))

510(k) K092278

by Gyrus Acmi, Inc.

Identifiers

510(k) Number
K092278 FDA 510(k)
FDA Product Code
HIH FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 884.1690 FDA 510(k)
Regulation Number
884.1690 FDA 510(k)
Advisory Committee
Obstetrics/Gynecology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Gyrus Acmi Invisio Digital Hysteroscope, Model IDH-4 is a semi-rigid (rigi-flex) hysteroscope that incorporates CMOS (complimentary medical oxide semi-conductor) sensor technology to generate an image. It is part of the Invisio Digital Hysteroscope System, which includes the IDC Invision Controller used to process the video signal from the hysteroscope to ensure brightness, image clarity and color.

The device is intended for use in obstetrics and gynecology procedures. It is a Class II medical device with FDA 510(k) clearance (K092278) and is substantially equivalent to predicate devices. The device is supplied as part of a system that includes the hysteroscope and controller, and it is regulated under number 884.1690.

Frequently asked questions

What is the Gyrus Acmi Invisio Digital Hysteroscope used for?

The Gyrus Acmi Invisio Digital Hysteroscope, Model IDH-4 is intended for use in obstetrics and gynecology procedures. It is a semi-rigid hysteroscope that incorporates CMOS sensor technology to generate images for visualization during medical procedures.

What components are included with the Invisio Digital Hysteroscope System?

The Invisio Digital Hysteroscope System includes the Gyrus Acmi Invisio Digital Hysteroscope (Model IDH-4) and the IDC Invision Controller. The controller processes the video signal from the hysteroscope to ensure brightness, image clarity, and color accuracy during procedures.

What is the regulatory classification of this device?

The Gyrus Acmi Invisio Digital Hysteroscope is a Class II medical device with FDA 510(k) clearance (K092278). It is substantially equivalent to predicate devices and is regulated under number 884.1690.

How is the Gyrus Acmi Invisio Digital Hysteroscope supplied?

The device is supplied as part of a system that includes both the hysteroscope and the controller. It is not supplied as a standalone device but as part of the complete Invisio Digital Hysteroscope System for use in medical procedures.

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: Gyrus Acmi Invisio Digital Hysteroscope, Model Idh-4 (K092278) — Fda ..., GYRUS ACMI INVISIO DIGITAL HYSTEROSCOPE, MODEL IDH-4… - FDA.report, fda.innolitics.com

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Gyrus Acmi, Inc.

Sources (1)

  • FDA 510(k) K092278 24 fields · synced Oct 1, 2026