# K142029: Myosure Hysteroscopic Tissue Removal System

- Pathway: 510(k) (Traditional)
- Applicant: Hologic, Inc.
- Decided: Nov 26, 2014 after 124 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: 4 generations back to K953695 (1995). 8 ancestors in all.
14 later devices descend from it; 3 cite it directly.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132015: Truclear Morcellation System and Truclear Morcellators, Smith & Nephew, Inc. (2013) Summary page 4.

## Most influential descendants
- K152723: Myosure Hysteroscopic Tissue Removal System and Myosure Tissue Removal Devices (2015), 6 descendants of its own
- K172566: Myosure Hysteroscopic Tissue Removal System and Myosure Tissue Removal Devices (2017), 5 descendants of its own
- K173901: MyoSure MANUAL Tissue Removal Device (2018), 4 descendants of its own
- K180825: Fluent Fluid Management System (2018), 2 descendants of its own
- K191538: Resectr Tissue Resection Device (2020), 1 descendant 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/K142029
Methodology: https://510kreport.com/methodology