# K152723: Myosure Hysteroscopic Tissue Removal System and Myosure Tissue Removal Devices

- Pathway: 510(k) (Special)
- Applicant: Hologic, Inc.
- Decided: Nov 13, 2015 after 52 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: 5 generations back to K953695 (1995). 9 ancestors in all.
6 later devices descend from it; 2 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)
- K142029: Myosure Hysteroscopic Tissue Removal System, Hologic, Inc. (2014) Summary page 4.

## Most influential descendants
- K172566: Myosure Hysteroscopic Tissue Removal System and Myosure Tissue Removal Devices (2017), 5 descendants of its own
- 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

## Indications for use
The MyoSure Tissue Removal System and 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/K152723
Methodology: https://510kreport.com/methodology