# K232902: EVA15 insufflator

- Pathway: 510(k) (Traditional)
- Applicant: Palliare, Ltd.
- Decided: May 2, 2024 after 227 days
- Product code: HIF (Insufflator, Laparoscopic)
- Device class: 2
- Regulation: 21 CFR 884.1730
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 12 generations back to K964171 (1997). 34 ancestors in all.
No later device cites it as a predicate yet.
3 of 35 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K222901: EVA15 insufflator, Palliare, Ltd. (2023) Summary page 4.

## Indications for use
The EVA15 Insufflator is intended for use in diagnostic and/or therapeutic endoscopic and laparoscopic procedures to distend the abdomen, rectum, colon, esophagus, stomach or thoracic cavity with up to 25 mmHg pressure, by filling it with gas and to evacuate surgical smoke.

Source page: https://510kreport.com/device/K232902
Methodology: https://510kreport.com/methodology