# K050639: Lumenis Versacut Tissue Morcellator System

- Pathway: 510(k) (Special)
- Applicant: Lumenis, Inc.
- Decided: Mar 31, 2005 after 17 days
- Product code: GCJ (Laparoscope, General & Plastic Surgery)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: 1 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K910939 (1991). 4 ancestors in all.
7 later devices descend from it; 2 cite it directly.
1 of 12 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K980079: Coherent Tissue Morcellator Kit and Accessories, Lumenis, Inc. (1998) Summary page 1.

## Most influential descendants
- K133272: Versacut + Tissue Morcellator (2014), 5 descendants of its own
- K192499: Cyber Blade (2020), 2 descendants of its own
- K213597: MultiCut Solo (2023), 1 descendant of its own
- K260884: UNIDRIVE Select System (2026), 0 descendants of its own
- K251923: Medical Shaver System (Morcellator) (YSB-IIIA) (2026), 0 descendants of its own

## Recalls of this device
- Jan 2, 2013 · Class I · Z-0795-2013: Lumenis Ltd is recalling certain models of VersaCut Morcellator devices to perform corrective labeling as a result of three reported events of air embolism secondary to incorrect reversal tubing syste

## Indications for use
The Lumenis VersaCut Tm Tissue Morcellator System is intended for use under direct or endoscopic visualization for the morcellation and removal of dissected tissue during pelviscopic, laparoscopic, percutaneous, and open surgical procedures whenever access to the surgical site is limited.

Source page: https://510kreport.com/device/K050639
Methodology: https://510kreport.com/methodology