# K131656: Morcellex Sigma Generator

- Pathway: 510(k) (Traditional)
- Applicant: ETHICON, Inc.
- Decided: Sep 27, 2013 after 113 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
Longest line of descent: 1 generation back to K954648 (1996). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K954648: Femrx Operastar System, Gynecare Innovation Center (1996) Summary page 1.

## Indications for use
The MORCELLEX SIGMA' m Generator is used with the following ETHICON Morceliation Devices: GYNECARE X-TRACT', GYNECARE MORCELLEX', and MORCELLEX SIGMA'. The MORCELLEX SIGMA Generator is used in conjunction with the ETH-ICON Morcellation Devices for gynecologic, urologic, and general surgical endloscopic use by trained professionals in hospital environments and ambulatory surgery centers. The MORCELLEX SIGMA TM Generator is used in conjunction with ETI-ICON Morcellation Devices 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/K131656
Methodology: https://510kreport.com/methodology