# K100280: Gyncare Morcellex Tissue Morcellator

- Pathway: 510(k) (Traditional)
- Applicant: ETHICON, Inc.
- Decided: Mar 24, 2010 after 51 days
- Product code: HET (Laparoscope, Gynecologic (And Accessories))
- Device class: 2
- Regulation: 21 CFR 884.1720
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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 MORCELLEX Tissue Morcellator: named in the summary without a submission number

## 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/K100280
Methodology: https://510kreport.com/methodology