# K014172: Nelson Electrosurgical Unit, Model GN640

- Pathway: 510(k) (Traditional)
- Applicant: Aesculap, Inc.
- Decided: Mar 19, 2002 after 89 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 K933002 (1994). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K981220: System 7500 Abc Electrosurgical Unit, Aspen Laboratories, Inc. (1998) Summary page 1.
- K953738: Erbotom Icc 300, Erbe Electromedizin GmbH (1995) Summary page 1.
- K933002: Erbotom Icc 350, Erbe USA, Inc. (1994) Summary page 1.
- K944602: Valleylab Force FX, Valleylab, Inc. (1995) Summary page 1.

## Indications for use
Aesculap's Nelson Electrosurgical is intended to be used in surgery to generate electrical power for both Monopolar and Bipolar cutting and coagulating in microsurgery and macrosurgery.

Source page: https://510kreport.com/device/K014172
Methodology: https://510kreport.com/methodology