# K091100: Myosure Hysteroscopic Tissue Removal System

- Pathway: 510(k) (Traditional)
- Applicant: Interlace Medical, Inc.
- Decided: Oct 23, 2009 after 190 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). 7 ancestors in all.
7 later devices descend from it; 2 cite it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073690: Interlace Medical Hysteroscopic Morcellation System, Interlace Medical, Inc. (2008) Summary page 1.
- K061050: Gynecare Morcellex Tissue Morcellator,  Models MX0100 and MX0100R, ETHICON, Inc. (2006) Summary page 1.

## Most influential descendants
- K100559: Myosure Hysteroscopic Tissue Removal System (2010), 6 descendants of its own
- K122498: Myosure XL Tissue Removal Device (1 Pack) Myosure XL Tissue Removal Device (3 Pack) (2012), 1 descendant of its own
- K131581: Myosure Tissue Removal Device (1 Pack and 3 Pack) (2013), 0 descendants of its own
- K131736: Myosure Tissue Removal Device (1 Pack), Myosure Tissue Removal Device (3 Pack) (2013), 0 descendants of its own
- K121868: Myosure Lite Tissue Removal Device (1 Pack), Myosure Lite Tissue Removal Device (3 Pack) (2012), 0 descendants of its own

## Indications for use
The MyoSURE TM 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/K091100
Methodology: https://510kreport.com/methodology