# K052009: Conmed System Model 2450 Electrosurgical Generator

- Pathway: 510(k) (Traditional)
- Applicant: Conmed Corporation
- Decided: Sep 28, 2005 after 65 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K905654 (1991). 3 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K905654: Electrosurgical Unit with Accessories, Aspen Labs (1991) Summary page 1.
- K020186: Conmed System 5000 Esu, Conmedcorp (2002) Summary page 1.
- K944602: Valleylab Force FX, Valleylab, Inc. (1995) Summary page 1.

## Most influential descendants
- 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
- K153499: EDGE Arthroscopic Energy System, Arthroscopic Energy System Probes, Arthroscopic Energy System Wireless Footswitch, Arthroscopic Energy System Corded Footswitch, Arthroscopic Energy System Foot Control, Extension (2015), 0 descendants of its own

## Recalls of this device
- Dec 27, 2010 · Not classified · Z-1365-2011: Electrosurgical generator may allow possibility of electrical shock and/or burns to user or patient.
- Dec 27, 2010 · Not classified · Z-1362-2011: Electrosurgical generator may allow possibility of electrical shock and/or burns to user or patient.
- Dec 27, 2010 · Not classified · Z-1363-2011: Electrosurgical generator may allow possibility of electrical shock and/or burns to user or patient.
- Dec 27, 2010 · Not classified · Z-1366-2011: Electrosurgical generator may allow possibility of electrical shock and/or burns to user or patient.
- Dec 27, 2010 · Not classified · Z-1364-2011: Electrosurgical generator may allow possibility of electrical shock and/or burns to user or patient.

## Indications for use
General-purpose electrosurgical generator used in conjunction with an electrosurgical accessory handpiece for delivery of RF (radio frequency) electrosurgical current through an accessory electrode for cutting and coagulation at the operative site.

Source page: https://510kreport.com/device/K052009
Methodology: https://510kreport.com/methodology