# K151480: Epix Electrosurgical Probe with Smoke Evacuation

- Pathway: 510(k) (Traditional)
- Applicant: Applied Medical Resources
- Decided: Feb 19, 2016 after 262 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K913108 (1991). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K981188: Electrosurgical Cautery Probes, Microline Pentax, Inc. (1998) Summary page 4.

## Indications for use
The Epix® Electrosurgical Probes with Smoke Evacuation (spatula, L-hook, needle tips) are intended to deliver energy from an independent monopolar electrosurgical generator to cut and coagulate tissue during laparoscopic (inclusive of endoscopic) surgical procedures where the device is introduced into the body through a cannula. The device may be used for the evacuation of smoke created by electrosurgery at the surgical site.

Source page: https://510kreport.com/device/K151480
Methodology: https://510kreport.com/methodology