# K091010: Trokamed Morcellator

- Pathway: 510(k) (Traditional)
- Applicant: Trokamed GmbH
- Decided: Mar 1, 2011 after 691 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
Longest line of descent: 5 generations back to K871250 (1987). 14 ancestors in all.
No later device cites it as a predicate yet.
0 of 15 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.
- K061180: Ksea Rotocut G1 Electromechanical Morcellator, KARL STORZ Endoscopy-America, Inc. (2006) Summary page 1.
- K041610: Morce Scope Set 8970 with Power Control 2303 and Suction Pump 2207, Richard Wolf Medical Instruments Corp. (2004) 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.

## Recalls of this device
- Jul 16, 2014 · Class II · Z-2145-2014: Some pages of the Instructions for Use were omitted, including pages regarding the Indications for Use, Warning, and Contraindications.

## Indications for use
The TROKAMED MORCELLATOR 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/K091010
Methodology: https://510kreport.com/methodology