# K081791: E-Z Clean Electrosurgical Electrode

- Pathway: 510(k) (Traditional)
- Applicant: Megadyne Medical Products, Inc.
- Decided: Oct 21, 2008 after 118 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: 2 generations back to K780977 (1978). 5 ancestors in all.
8 later devices descend from it; 4 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K862221: E-Z Clean, American Medical Products, Inc. (1986) Summary page 2.
- K960255: Ceramic Blade Electrode, Utah Medical Products, Inc. (1996) Summary page 2.

## Most influential descendants
- K091672: Disposable Grounding Pad Series and Electrode Series (2009), 3 descendants of its own
- K220725: HPR45i (2023), 1 descendant of its own
- K152059: Disposable General Electrode (2016), 1 descendant of its own
- K252704: F Care RF System (00MEDRF4000US, 05RAFAELOPROBE, 05SPHERAPROBE, 06OUTPUTKAB, 06Pedal1St) (2025), 0 descendants of its own
- K240868: Ultravision2™ IonPencil (2024), 0 descendants of its own

## Recalls of this device
- Oct 13, 2009 · Not classified · Z-0486-2010: Product labels reference an incorrect expiration date. Expiration date referenced on labels is 2104-07 instead of 2014-07.

## Indications for use
E-Z Clean electrosurgical electrodes are intended to conduct radio frequency (RF) current for cutting and coagulation from the RE electrosurgical generator to target soft tissue in a broad range of surgical procedures requiring the use of electrosurgery for cutting and cauterization. Some tip configurations have a specific geometry that minimizes blanching and thermal damage in skin incisions when used in conjunction with the generator's Advanced Cutting Effect (ACE) mode.

Source page: https://510kreport.com/device/K081791
Methodology: https://510kreport.com/methodology