# K073616: Fas-Clean Electrosurgical Coated Active Blade

- Pathway: 510(k) (Traditional)
- Applicant: Electromedics Co., Ltd.
- Decided: Jul 23, 2008 after 210 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 K033003 (2004). 5 ancestors in all.
25 later devices descend from it; 1 cites it directly.
0 of 31 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.
- K962044: Valleylab Coated Electrodes, Valleylab, Inc. (1996) Summary page 1.
- K052104: Ultraclean Handcontrolled Suction Coagulator, Model 130182, 130183, 130184, 130185; Ultraclean Footcontrolled Suction, Conmed Corporation (2005) Summary page 1.
- K943055: Electrosurgical Cutting and Coagulating Device and Accessories, Megadyne Medical Products, Inc. (1994) Summary page 1.

## Most influential descendants
- K082786: Pulsar Generator, Peak Plasmablade; 4.0, Needle, and Ext Tissue Dissection Devices (2008), 24 descendants of its own
- K093695: Peak Plasmablade 3.OS Tissue Dissection Device (2010), 8 descendants of its own
- K142410: Elliquence Electrodes (2015), 7 descendants of its own
- K160041: Cobbra RF Tissue Dissector (2016), 6 descendants of its own
- K183611: Soniquence RF Generator and Soniquence Electrodes (2019), 5 descendants of its own

## Indications for use
The FAS-CLEAN Electrosurgical Coated Active Blade, a single use, sterile, monopolar, Emralon coated electrode is intended for use: * In surgical procedures (general, neurosurgical, laparoscopic, orthopedic, and gynecologic) where monopolhr electrosurgical cutting and coagulation are normally used. * As an alternative to uncoated stainless steel electrodes or "non-stick" coated electrodes, which are used for these indications.

Source page: https://510kreport.com/device/K073616
Methodology: https://510kreport.com/methodology