# K061878: Electrode Coated Ball, Model AB302C; Needle, Model AN301C; Blade, Model AE301HC

- Pathway: 510(k) (Traditional)
- Applicant: E Surgical, LLC
- Decided: Oct 24, 2006 after 113 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: 1 generation back to K962044 (1996). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K962044: Valleylab Coated Electrodes, Valleylab, Inc. (1996) Summary page 1.
- K982742: Disposable Hand Switching Pencil, Rocker Switch, One Piece and One Piece Holster Models SB 313 RS, SB 313 RSH, New Deantronics Taiwan, Ltd. (1998) Summary page 1.

## Indications for use
E Surgical Coated Electrodes are intended as an alternative to uncoated stainless steel electrodes or "non-stick" coated electrodes for use in conventiorial monopolar electrosurgical accessories. The Coated Electrodes are intended for use in situations where monopolar electrosurgical cutting and coagulation are normally used.

Source page: https://510kreport.com/device/K061878
Methodology: https://510kreport.com/methodology