# K171684: Epix Electrosurgical Probe with Smoke Evacuation

- Pathway: 510(k) (Traditional)
- Applicant: Applied Medical Resources Corporation
- Decided: Aug 7, 2017 after 61 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- 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: 2 generations back to K983623 (1998). 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)
- K132300: Epix Electrosurgical Probe Spatula Tip, Epix Electrosurgical Probe L-Hook Tip, Epix Electrosurgical Probe J-Hook Tip, RE, Applied Medical Resources Corp. (2014) Summary page 4.

## Recalls of this device
- Dec 12, 2018 · Class II · Z-0509-2020: Unintentional shifting of the tip insulation of the firm's electrosurgical probes.

## Indications for use
The Epix Electrosurgical Probe with Smoke Evacuation is intended to deliver energy from an independent monopolar electrosurgical generator to cut and coagulate tissue during laparoscopic 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/K171684
Methodology: https://510kreport.com/methodology