# K960808: Conmed Select One Laparoscopy Electrode

- Pathway: 510(k) (Traditional)
- Applicant: Conmedcorp
- Decided: Mar 21, 1996 after 22 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Recalls of this device
- Aug 9, 2004 · Not classified · Z-1413-04: Insulation may pull away from the hub of the electrode exposing the conductive shaft below. This condition results in potential for electrical shock.
- Aug 9, 2004 · Not classified · Z-1412-04: Insulation may pull away from the hub of the electrode exposing the conductive shaft below. This condition results in potential for electrical shock.
- Jun 28, 2004 · Not classified · Z-1301-04: Insulation of some electrodes may have pulled away from the hub of the electrode exposing the conductive shaft below. There is potential for electrical shock.

Source page: https://510kreport.com/device/K960808
Methodology: https://510kreport.com/methodology