# K080365: Morce Power Plus and Variocarve Morcellator

- Pathway: 510(k) (Traditional)
- Applicant: Nouvag AG
- Decided: Jun 29, 2009 after 504 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 K960640 (1997). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K993801: Gynecare Laparoscopic Morcellator, ETHICON, Inc. (2000) Summary page 1.
- K960640: S*E*M*M* Set for Moto Drive Wisap #7689 SSM (Modification), Wisap Gesellschaft Fur Wissenschaftl. App. Bau Mbh (1997) Summary page 1.
- K982515: Power-Drive, Wisap Model #7688PD/7688PD1, Wisap Gesellschaft Fur Wissenschaftl. App. Bau Mbh (1999) Summary page 1.

## Indications for use
The Morce Power Plus morcellator is intended for use in operative laparoscopy, including laparoscopic general surgical procedures and laparoscopic gynecological procedures to morcellate and remove tissue. The VarioCarve morcellator is intended for morcellating and extracting tissue (e.g. removing myomata or the uterus) during laparoscopic procedures in general surgery and gynecology.

Source page: https://510kreport.com/device/K080365
Methodology: https://510kreport.com/methodology