# K905654: Electrosurgical Unit with Accessories

- Pathway: 510(k) (Traditional)
- Applicant: Aspen Labs
- Decided: Mar 18, 1991 after 90 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
No predicates in its family tree.
4 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K052009: Conmed System Model 2450 Electrosurgical Generator (2005), 3 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
- 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

Source page: https://510kreport.com/device/K905654
Methodology: https://510kreport.com/methodology