# K030473: Senorx ES-300

- Pathway: 510(k) (Traditional)
- Applicant: Senorx, Inc.
- Decided: Feb 26, 2003 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: 1 generation back to K944602 (1995). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K944602: Valleylab Force FX, Valleylab, Inc. (1995) Summary page 1.
- K001253: Surgitron Iec II, Ellman Intl., Inc. (2000)
- K001407: Surgitron Iec II, Ellman Intl., Inc. (2000)

## Indications for use
The SenoRx ES 300 is an electrosurgical generator which is intended for general surgical procedures where electrosurgical cutting or coagulation of soft tissues is required.

Source page: https://510kreport.com/device/K030473
Methodology: https://510kreport.com/methodology