# K061050: Gynecare Morcellex Tissue Morcellator,  Models MX0100 and MX0100R

- Pathway: 510(k) (Traditional)
- Applicant: ETHICON, Inc.
- Decided: Jul 14, 2006 after 88 days
- Product code: HET (Laparoscope, Gynecologic (And Accessories))
- Device class: 2
- Regulation: 21 CFR 884.1720
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
8 later devices descend from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) GYNECARE X-TRACT Tissue Morcellator: named in the summary without a submission number

## Most influential descendants
- K091100: Myosure Hysteroscopic Tissue Removal System (2009), 7 descendants of its own
- 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

## Recalls of this device
- Sep 28, 2009 · Not classified · Z-0173-2010: There is the potential for the duckbill seal to become dislodged.

## Indications for use
The GYNECARE MORCELLEX Tissue Morcellator is indicated for cutting, coring and extracting tissue during operative laparoscopy, including laparoscopic general surgical procedures, laparoscopic urologic procedures, and laparoscopic gynecologic procedures.

Source page: https://510kreport.com/device/K061050
Methodology: https://510kreport.com/methodology