# K041980: Msi S-500L RF Generator

- Pathway: 510(k) (Special)
- Applicant: Medsphere International, Inc.
- Decided: Aug 6, 2004 after 14 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
Longest line of descent: 2 generations back to K963772 (1996). 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)
- K033888: Msi Model S-500 RF Generator, Medsphere International, Inc. (2004) Summary page 1.

## Indications for use
Indicated for coagulation of soft tissue These devices are intended for use by qualified medical personnel trained in the use of electrosurgery.

Source page: https://510kreport.com/device/K041980
Methodology: https://510kreport.com/methodology