# K133272: Versacut + Tissue Morcellator

- Pathway: 510(k) (Traditional)
- Applicant: Lumenis, Ltd.
- Decided: May 13, 2014 after 201 days
- Product code: GCJ (Laparoscope, General & Plastic Surgery)
- Device class: 2
- Regulation: 21 CFR 876.1500
- 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: 3 generations back to K910939 (1991). 5 ancestors in all.
5 later devices descend from it; 2 cite it directly.
1 of 11 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050639: Lumenis Versacut Tissue Morcellator System, Lumenis, Inc. (2005) Summary page 3.

## Most influential descendants
- 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
- K240831: MultiCut Solo (2024), 0 descendants of its own

## Recalls of this device
- Jul 30, 2015 · Class II · Z-2770-2015: There is a probability the hand piece may operate inconsistently and unpredictably during the morcellation procedure resulting in damage to non-target tissue.

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

Source page: https://510kreport.com/device/K133272
Methodology: https://510kreport.com/methodology