# K012684: Reprocessed Electrosurgical Electrode

- Pathway: 510(k) (Traditional)
- Applicant: Sterilmed, Inc.
- Decided: Jan 18, 2002 after 157 days
- Product code: JOS (Electrode, Electrosurgical)
- 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 K000348 (2000). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K000348: Colorado Microdissection Needle, Stryker Leibinger (2000) Summary page 1.

## Recalls of this device
- Aug 8, 2008 · Not classified · Z-0552-2009: SteriMed, Inc is conducting a product removal of a small group of devices individually packaged and sealed within a pouch. The removal is being conducted because the possibility exists that some of th

## Indications for use
Reprocessed electrosurgical electrodes are intended for precision cutting, dissecting and cauterizing of soft tissue. These devices are most commonly used in surgical procedures for which minimal tissue necrosis, bleeding, and surgical field smoke is desired.

Source page: https://510kreport.com/device/K012684
Methodology: https://510kreport.com/methodology