# K020135: Conmed System 2000 Electrosurgical Generator, Ref: 60-8002; Conmed Esu Cart, Ref: 60-6120

- Pathway: 510(k) (Traditional)
- Applicant: Conmedcorp
- Decided: Apr 12, 2002 after 87 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.
No later device cites it as a predicate yet.
0 of 1 device 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.

## Recalls of this device
- Sep 5, 2006 · Not classified · Z-1507-06: 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 with an electrosurgical accessory handpiece for delivery of a RF (radio frequency) electrosurgical current through an accessory electrode for cutting and coagulation at the operative site.

Source page: https://510kreport.com/device/K020135
Methodology: https://510kreport.com/methodology