# K132224: Unimed Surgical Coated Electrosurgical Electrodes

- Pathway: 510(k) (Traditional)
- Applicant: Unimed Surgical Products, Inc.
- Decided: Oct 8, 2013 after 83 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 K945030 (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)
- K970066: Unimed Coated Laparoscopic/Arthroscopy/Suction-Irrigation Electrode, Unimed Surgical Products, Inc. (1997) Summary page 1.
- K962935: Unimed Coated Needle Electrode/Coated Blade Electrode/Coated Ball Electrode, Unimed Surgical Products, Inc. (1996) Summary page 1.

## Indications for use
The Coated Electrosurgical Electrodes are intended for the following indications: *Cutting of Soft Tissue *Coagulation of Soft Tissue

Source page: https://510kreport.com/device/K132224
Methodology: https://510kreport.com/methodology