# K984275: The Golden Tip Electro-Surgical Probe

- Pathway: 510(k) (Traditional)
- Applicant: Amada Surgical
- Decided: Feb 1, 1999 after 63 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 K903302 (1990). 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)
- K962044: Valleylab Coated Electrodes, Valleylab, Inc. (1996) Summary page 1.
- K903302: Electrode, Electrosurgery, Megadyne Medical Products, Inc. (1990) Summary page 1.

## Cited in the summary but kept off the family tree
- K096402: Davis-Bayonet Electrodes. Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Indications for use
The Golden Tip™ Electro-Surgical Probe is an electrocautery electrode and intended for use in open surgical procedures.

Source page: https://510kreport.com/device/K984275
Methodology: https://510kreport.com/methodology