# K172566: Myosure Hysteroscopic Tissue Removal System and Myosure Tissue Removal Devices

- Pathway: 510(k) (Special)
- Applicant: Hologic, Inc.
- Decided: Sep 20, 2017 after 26 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: 6 generations back to K953695 (1995). 10 ancestors in all.
5 later devices descend from it; 3 cite it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152723: Myosure Hysteroscopic Tissue Removal System and Myosure Tissue Removal Devices, Hologic, Inc. (2015) Summary page 4.

## Most influential descendants
- K180825: Fluent Fluid Management System (2018), 2 descendants of its own
- K181974: MyoSure XL Tissue Removal Device for Fluent (2018), 1 descendant of its own
- K240886: Fluent Pro Fluid Management System (FLT-200); Fluent Pro Fluid Management System Disposable Procedure Kit (6-pack) (FLT-212); Fluent Pro Fluid Management System Disposable Procedure Kit (1-pack) (FLT-212S); Fluent Pro Fluid Management System Tissue Trap Multipack (10-pack) (FLT-210); Fluent Pro Fluid Management System Waste Bag Multipack (5-pack) (FLT-205) (2024), 0 descendants of its own
- K233710: Symphion Operative Hysteroscopy System (2024), 0 descendants of its own
- 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 Hysteroscopic Tissue Removal System and Myosure Tissue Removal Devices are 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/K172566
Methodology: https://510kreport.com/methodology