# K223373: Enivo™

- Pathway: 510(k) (Traditional)
- Applicant: Aroa Biosurgery, Ltd.
- Decided: Apr 7, 2023 after 154 days
- Product code: BTA (Pump, Portable, Aspiration (Manual Or Powered))
- Device class: 2
- Regulation: 21 CFR 878.4780
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K883582 (1988). 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)
- K222856: SOMAVAC 100 Sustained Vacuum System, Somavac Medical Solutions, Inc. (2022) Summary page 4.

## Indications for use
Enivo™ is indicated for use to remove surgical and bodily fluids from a closed wound for hematoma and seroma prophylaxis following plastic surgery or other general surgeries where large flaps are formed.

Source page: https://510kreport.com/device/K223373
Methodology: https://510kreport.com/methodology