MyoSure XL Tissue Removal Device (1 Pack) | MyoSure XL Tissue Removal Device (3 Pack)
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K122498 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 XL Tissue Removal Device is classified as a Hysteroscope (and Accessories) and is designed for hysteroscopic intrauterine procedures. It is intended for the resection and removal of tissue, including submucous myomas, endometrial polyps, and retained products of conception, during gynecological interventions.
This device is supplied as a single-use, sterile instrument, available in 1-pack or 3-pack configurations. It is intended for use in MRI-unsafe environments and requires no special storage conditions beyond standard medical device handling. Authorized under FDA 510(k) clearance (K122498) and MDR compliance, it is regulated under the classification of Class II medical devices.
Frequently asked questions
What types of uterine tissue can the MyoSure XL Tissue Removal Device remove during hysteroscopic procedures?
The MyoSure XL Tissue Removal Device is specifically designed for hysteroscopic resection and removal of submucous myomas (fibroids), endometrial polyps, and retained products of conception during gynecological interventions.
Is the MyoSure XL Tissue Removal Device intended for use in MRI environments, and what are its storage requirements?
The device is explicitly intended for use in MRI-unsafe environments, meaning it should not be used where MRI compatibility is required. Storage only requires standard medical device handling—no special conditions are specified.
How is the MyoSure XL Tissue Removal Device packaged and supplied for clinical use?
The device is supplied as a single-use, sterile instrument in two configurations: a 1-pack or a 3-pack format, ensuring convenience for clinical procedures.
What regulatory pathway does the MyoSure XL Tissue Removal Device follow, and which medical specialty is it primarily associated with?
The device is authorized under FDA 510(k) clearance (K122498) and MDR compliance, classified as a Class II medical device. It is regulated under the Obstetrics/Gynecology specialty category, as indicated by its advisory committee designation.
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, Hologic 50-601XL MyoSure XL Tissue Removal Device for Fluent - XS Supply
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K122498 | Class II | Active |
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Manufacturer
- Manufacturer
- Hologic, Inc.
Sources (2)
- FDA 510(k) K122498 24 fields · synced Oct 6, 2026
- EUDAMED 1 fields · synced May 19, 2026