# K181974: MyoSure XL Tissue Removal Device for Fluent

- Pathway: 510(k) (Special)
- Applicant: Hologic, Inc.
- Decided: Aug 23, 2018 after 30 days
- Product code: HIH (Hysteroscope (And Accessories))
- Device class: 2
- Regulation: 21 CFR 884.1690
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K953695 (1995). 11 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172566: Myosure Hysteroscopic Tissue Removal System and Myosure Tissue Removal Devices, Hologic, Inc. (2017) Summary page 4.

## Most influential descendants
- K201756: Reprocessed MyoSure Tissue Removal Device, Reprocessed MyoSure REACH Tissue Removal Device, Reprocessed MyoSure LITE Tissue Removal Device, Reprocessed MyoSure XL Tissue Removal Device, Reprocessed MyoSure XL Tissue Removal Device for Fluent (2020), 0 descendants of its own

## Indications for use
The MyoSure XL Tissue Removal Device for Fluent in intended for intrauterine use by trained gynecologists to hysteroscopically resect and remove tissue such as: Submucous myomas Endometrial Polyps Retained products of conception.

Source page: https://510kreport.com/device/K181974
Methodology: https://510kreport.com/methodology