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TruClear Elite Hysteroscope

FDA 510(k)

Class II (US FDA 510(k))

510(k) K180496

by Covidien

Identifiers

510(k) Number
K180496 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)

A hysteroscope is a device used for visual examination of the uterine cavity. The TruClear Elite Hysteroscope is a hysteroscopic instrument designed for gynecological procedures.

It is supplied as a reusable device with a 7.25mm diameter and 0° angle, featuring a long working channel and integrated continuous inflow and outflow system. The device is classified as Class II under FDA regulation number 884.1690 and has received FDA 510(k) clearance (K180496) as substantially equivalent to a predicate device.

Frequently asked questions

What is the TruClear Elite Hysteroscope used for?

The TruClear Elite Hysteroscope is designed for visual examination of the uterine cavity during gynecological procedures, allowing clinicians to inspect the endometrium and uterine cavity for diagnostic or operative purposes.

Is the TruClear Elite Hysteroscope reusable or single-use?

The TruClear Elite Hysteroscope is supplied as a reusable device, meaning it can be cleaned, sterilized, and used for multiple procedures following the manufacturer's reprocessing instructions.

What are the key specifications of the TruClear Elite Hysteroscope?

The TruClear Elite Hysteroscope has a 7.25mm diameter and a 0° angle of view, includes a long working channel, and features an integrated continuous inflow and outflow system to maintain distension and visualization during hysteroscopic 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: TruClear™ Elite hysteroscope - Medtronic, Covidien TruClear Elite Hysteroscope | 72204879/72205067, Covidien TruClear Elite Hysteroscope - Medical Grade 7.25mm, Covidien TruClear Elite Hysteroscope plus| 72204879/72205 - eBay

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Covidien

Sources (1)

  • FDA 510(k) K180496 24 fields · synced Sep 22, 2026