# K970066: Unimed Coated Laparoscopic/Arthroscopy/Suction-Irrigation Electrode

- Pathway: 510(k) (Traditional)
- Applicant: Unimed Surgical Products, Inc.
- Decided: Feb 18, 1997 after 41 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K945030 (1994). 3 ancestors in all.
3 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)
- K962935: Unimed Coated Needle Electrode/Coated Blade Electrode/Coated Ball Electrode, Unimed Surgical Products, Inc. (1996) Summary page 1.
- K945030: Surgi-Link Laparoscopic Electrodes, Unimed Surgical Products, Inc. (1994) Summary page 1.
- K963338: Unimed Suction-Irrigation Electrode and Sliding Sheath, Unimed Surgical Products, Inc. (1996) Summary page 1.

## Most influential descendants
- K020579: Aaron Arthroscopy Electrode, Catalog Numbers AR00, AR01, AR02, and AR03 (2002), 1 descendant of its own
- K170703: Single Use Arthroscopic Electrode (with Pencil) (2018), 0 descendants of its own
- K132224: Unimed Surgical Coated Electrosurgical Electrodes (2013), 0 descendants of its own

## Recalls of this device
- Feb 15, 2013 · Class II · Z-1347-2013: Firm is recalling due to concerns regarding changes that were made to the PTFE coating materials.

Source page: https://510kreport.com/device/K970066
Methodology: https://510kreport.com/methodology