# K101413: Euromi Eva SP6

- Pathway: 510(k) (Traditional)
- Applicant: Euromi S.A
- Decided: Dec 16, 2010 after 210 days
- Product code: QPB (System, Suction, Lipoplasty For Removal)
- Device class: 2
- Regulation: 21 CFR 878.5040
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K895761 (1989). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K981215: Psi-Tec Liposuction Aspirator, Byron Medical (1998) Summary page 5.
- K040149: Psi-Tec Peristaltic Infiltration Pump, Byron Medical (2004) Summary page 5.

## Indications for use
The device is intended to be used for aesthetic body contouring.

Source page: https://510kreport.com/device/K101413
Methodology: https://510kreport.com/methodology