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Myosure Hysteroscopic Tissue Removal System and Myosure Tissue Removal Devices

FDA 510(k)

Class II (US FDA 510(k))

510(k) K152723

by Hologic, Inc.

Identifiers

510(k) Number
K152723 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 Myosure Hysteroscopic Tissue Removal System and Myosure Tissue Removal Devices is a hysteroscopic tissue removal system and accessories. It is classified as a Hysteroscope (And Accessories) under device class 2.

The device is supplied non-sterile and is intended for reuse after appropriate cleaning and sterilization. It is used in hysteroscopic intrauterine procedures by trained gynecologists to resect and remove tissue including submucous myomas, endometrial polyps, and retained products of conception. The device received FDA 510(k) clearance (K152723) on November 13, 2015, and is authorized for use in the United States.

Frequently asked questions

What is the Myosure Hysteroscopic Tissue Removal System used for?

The Myosure Hysteroscopic Tissue Removal System is used by trained gynecologists to resect and remove tissue including submucous myomas, endometrial polyps, and retained products of conception during hysteroscopic intrauterine procedures.

Is the Myosure Tissue Removal Device supplied sterile or non-sterile, and is it intended for single use or reuse?

The Myosure Tissue Removal Device is supplied non-sterile and is intended for reuse after appropriate cleaning and sterilization, as specified in the device labeling and manufacturer instructions.

What regulatory pathway was used for the Myosure Hysteroscopic Tissue Removal System, and when was it cleared?

The Myosure Hysteroscopic Tissue Removal System received FDA 510(k) clearance under submission K152723 on November 13, 2015, and is authorized for use in the United States.

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: MyoSure® Tissue Removal System | Hysteroscopic | Hologic, MyoSure Tissue Removal System | Hologic, MyoSure tissue removal products - Hologic, MyoSure® Tissue Removal | Hysteroscopy | Hologic® Canada, Hysteroscopic Surgery Solution | MyoSure® | Hologic® UK

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Hologic, Inc.

Sources (1)

  • FDA 510(k) K152723 24 fields · synced Oct 6, 2026