# 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

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Sustainability Solutions
- Decided: Sep 25, 2020 after 88 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: 8 generations back to K953695 (1995). 12 ancestors in all.
No later device cites it as a predicate yet.
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.
- K152723: Myosure Hysteroscopic Tissue Removal System and Myosure Tissue Removal Devices, Hologic, Inc. (2015) Summary page 4.
- K181974: MyoSure XL Tissue Removal Device for Fluent, Hologic, Inc. (2018) Summary page 4.

## Indications for use
The Reprocessed MyoSure Tissue Removal Device (Model# 10-401/10-403) is indicated for intrauterine use by trained gynecologists to hysteroscopically resect and remove tissue such as: submucous myomas, endometrial polyps, and retained products of conception. The Reprocessed MyoSure REACH Tissue Removal Device (Model# 10-401FC/10-403FC) is indicated for intrauterine use by trained gynecologists to hysteroscopically resect and remove tissue such as: submucous myomas, endometrial polyps, and retain products of conception. The Reprocessed MyoSure LITE Tissue Removal Device (Model # 30-40 I LITE/30-403LITE) is indicated for intrauterine use by trained gynecologists to hysteroscopically resect and remove tissue such as: submucous myomas, endometrial polyps, and retain products of conception. The Reprocessed MyoSure XL Tissue Removal Device (Model# 50-501XL/50-503XL) is indicated for intrauterine use by trained gynecologists to hysteroscopically resect and remove tissue such as: submucous myomas, endometrial polyps, and retain products of conception. The Reprocessed MyoSure XL Tissue Removal Device for Fluent (Model# 50-601XL/50-603XL) is indicated for intrauterine use by trained gynecologists to hysteroscopically resect and remove tissue such as: submucous myomas, endometrial polyps, and retain products of conception.

Source page: https://510kreport.com/device/K201756
Methodology: https://510kreport.com/methodology