← Back to catalogue

MyoSure Lite Tissue Removal Device (1 Pack), MyoSure Lite Tissue Removal Device (3 Pack)

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K121868

by Hologic, Inc.

Identifiers

510(k) Number
K121868 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 Lite Tissue Removal Device is a hysteroscopic accessory designed for the removal of intrauterine tissue, including endometrial polyps and submucosal fibroids. Classified as a Class II device, it is intended for use in conjunction with a hysteroscope to facilitate minimally invasive gynecological procedures.

Supplied as a single-use, sterile instrument, the device features a lightweight and precise design with a 3 mm outer diameter and a length of 64.14 mm. It is intended for use in office-based settings and is authorized under FDA 510(k) clearance and MDR. The device is packaged in either one or three units per pack, ensuring compatibility with hysteroscopic systems for targeted tissue resection.

Frequently asked questions

What types of intrauterine tissue can the MyoSure Lite Tissue Removal Device remove, and how is it used in a clinical setting?

The MyoSure Lite Tissue Removal Device is designed specifically for the removal of intrauterine tissue, including endometrial polyps and submucosal fibroids. It is used as an accessory with a hysteroscope during minimally invasive gynecological procedures, allowing precise tissue resection in office-based settings.

Is the MyoSure Lite Tissue Removal Device intended for single-use or can it be reused?

The MyoSure Lite Tissue Removal Device is supplied as a single-use, sterile instrument. This ensures patient safety and reduces the risk of cross-contamination, as it is not intended for reuse.

What are the available packaging options for the MyoSure Lite Tissue Removal Device, and how does this affect compatibility?

The device is available in two packaging options: a single-pack (1 unit) or a multi-pack (3 units). Both options are designed to be compatible with standard hysteroscopic systems, making it convenient for clinical settings with varying procedural needs.

What are the physical dimensions of the MyoSure Lite Tissue Removal Device, and how might this impact its use?

The device has a lightweight and precise design with a 3 mm outer diameter and a length of 64.14 mm, making it suitable for targeted tissue resection in confined uterine spaces while minimizing patient discomfort during office-based procedures.

What regulatory pathways has the MyoSure Lite Tissue Removal Device followed, and what does this mean for its use?

The device has been authorized under FDA 510(k) clearance and MDR (Medical Device Regulation). This means it has undergone regulatory review to demonstrate safety and effectiveness for its intended use as a hysteroscopic accessory in gynecological procedures, ensuring compliance with both U.S. and EU standards.

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, Hologic MyoSure LITE 30-401LITE | Tissue Removal Device for ..., 30-401LITE - HOLOGIC | Tissue Removal System, 3 mm OD x 64.14 ...

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Hologic, Inc.

Sources (2)

  • FDA 510(k) K121868 24 fields · synced Oct 6, 2026
  • EUDAMED 1 fields · synced May 18, 2026