# K020186: Conmed System 5000 Esu

- Pathway: 510(k) (Traditional)
- Applicant: Conmedcorp
- Decided: Apr 12, 2002 after 84 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
No predicates in its family tree.
8 later devices descend from it; 3 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K152860: Helixar Electrosurgical Generator with Argon Beam Coagulation, Helixar Mobile Pedestal (2015), 3 descendants of its own
- K052009: Conmed System Model 2450 Electrosurgical Generator (2005), 3 descendants of its own
- K172671: HelixAR Electrosurgical Generator with Argon Beam Coagulation, HelixAR Mobile Pedestal (2017), 2 descendants of its own
- K103665: Conmed R Sabre Genesis TM Electrosurgical Unit; Coned R Sabre Genesis TM Electrosurgical Unit (230V); Conmed Hyfresurg O (2011), 2 descendants of its own
- K140578: Arthroscopic Energy System (2014), 1 descendant of its own

## Recalls of this device
- Sep 5, 2006 · Not classified · Z-1508-06: Wrong size capacitor installed in electrosurgical generator could malfunction, causing muscle stimulation or delay in therapy.

## Indications for use
General-purpose electrosurgical generator used in conjunction wuth an electrosurgical accessory handpiece for delivery of gaRF (radi frequency) electrosurgical current through an accessoryge}ectrefie for cutting and coagulation at the operative site.

Source page: https://510kreport.com/device/K020186
Methodology: https://510kreport.com/methodology