# K061180: Ksea Rotocut G1 Electromechanical Morcellator

- Pathway: 510(k) (Traditional)
- Applicant: KARL STORZ Endoscopy-America, Inc.
- Decided: Jul 27, 2006 after 91 days
- Product code: GCJ (Laparoscope, General & Plastic Surgery)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 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 no predicate by number.

## Most influential descendants
- K091010: Trokamed Morcellator (2011), 0 descendants of its own

## Indications for use
The ROTOCUT GI Electromechanical Morcellator in conjunction with the UNIDRIVE GYN Control unit is a motorized unit for morcellating and extracting tissue during laparoscopic procedures in general surgery, gynecology including the removal of myomas and hysterectomy, and urology including nephrectomy.

Source page: https://510kreport.com/device/K061180
Methodology: https://510kreport.com/methodology