# K210338: Edge Insulated Blade Electrode

- Pathway: 510(k) (Traditional)
- Applicant: Covidien, LLC
- Decided: Apr 15, 2021 after 69 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: 3 generations back to K780977 (1978). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081791: E-Z Clean Electrosurgical Electrode, Megadyne Medical Products, Inc. (2008) Summary page 4.

## Indications for use
The EdgeTM Insulated Blade Electrode is intended to conduct radio frequency (RF) current for cutting and coagulation from the RF electrosurgical generator to target soft tissue in a broad range of surgical procedures requiring the use of electrosurgery for cutting and cauterization.

Source page: https://510kreport.com/device/K210338
Methodology: https://510kreport.com/methodology