# K012799: ES-2000 Shape Select Electrosurgical Scalpel

- Pathway: 510(k) (Traditional)
- Applicant: Senorx, Inc.
- Decided: Sep 4, 2001 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 K790187 (1979). 4 ancestors in all.
2 later devices descend from it; 2 cite 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)
- K944602: Valleylab Force FX, Valleylab, Inc. (1995) Summary page 1.
- K001253: Surgitron Iec II, Ellman Intl., Inc. (2000) Summary page 1.
- K001407: Surgitron Iec II, Ellman Intl., Inc. (2000) Summary page 1.
- K790187: Bovie Hand Control, Sybron Corp. (1979) Summary page 1.

## Most influential descendants
- K070275: Flexible Loop Electrosurgical Electrode (2007), 0 descendants of its own
- K021707: Single Step Biopsy Device, Single Step Surgical Handle, Single Step Driver, Single Step Holders (2002), 0 descendants of its own

## Indications for use
The SenoRx ES-2000 electrosurgical generator and accessories are intended for general surgical procedures where electrosurgical cutting or coagulation of soft tissues is required. It is not intended for use on the skin or where electrosurgery is contraindicated.

Source page: https://510kreport.com/device/K012799
Methodology: https://510kreport.com/methodology