Myosure Hysteroscopic Tissue Removal System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K142029 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 is a hysteroscopic device designed for tissue removal in a minimally invasive procedure. It is used for hysteroscopic intrauterine procedures to resect and remove tissue, including submucous myomas, endometrial polyps, and retained products of conception.
The system is supplied for use in medical settings, including operating rooms and outpatient facilities. It is a single-use device, and its use is intended for trained gynecologists. The device has been cleared by the FDA, with a product code of HIH and a regulation number of 884.1690.
Frequently asked questions
What is the Myosure Hysteroscopic Tissue Removal System used for?
The Myosure system is used for hysteroscopic intrauterine procedures to resect and remove tissue, including submucous myomas, endometrial polyps, and retained products of conception.
Is the Myosure system a single-use device?
Yes, the Myosure Hysteroscopic Tissue Removal System is intended for single-use and is designed for use by trained gynecologists in medical settings.
What are the regulatory clearances for the Myosure system?
The Myosure system has been cleared by the FDA with a product code of HIH and a regulation number of 884.1690.
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® Canada
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K142029 | Class II | Active |
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Manufacturer
- Manufacturer
- Hologic, Inc.
Sources (1)
- FDA 510(k) K142029 24 fields · synced Sep 26, 2026