# K122498: Myosure XL Tissue Removal Device (1 Pack) Myosure XL Tissue Removal Device (3 Pack)

- Pathway: 510(k) (Special)
- Applicant: Hologic, Inc.
- Decided: Sep 10, 2012 after 25 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). 9 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100559: Myosure Hysteroscopic Tissue Removal System, Interlace Medical, Inc. (2010) Summary page 1.

## Most influential descendants
- K131736: Myosure Tissue Removal Device (1 Pack), Myosure Tissue Removal Device (3 Pack) (2013), 0 descendants of its own

## Indications for use
The Myosure Hysteroscopic Tissue Removal System is intended for hysteroscopic intrauterine procedures by a trained gynecologist to resect and remove tissue including submucous myomas and endometrial polyps.

Source page: https://510kreport.com/device/K122498
Methodology: https://510kreport.com/methodology