# K033880: Electro-Lube

- Pathway: 510(k) (Traditional)
- Applicant: Mectra Labs, Inc.
- Decided: Mar 10, 2004 after 86 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
No predicates in its family tree.
3 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K241055: Electro Lube NXT (2024), 1 descendant of its own
- K242773: Electro Lube NXT (2025), 0 descendants of its own
- K052907: Polarcoat (2006), 0 descendants of its own

## Indications for use
Electro-Lube is a single patient use device that is intended to be used on electrodes to reduce sticking.

Source page: https://510kreport.com/device/K033880
Methodology: https://510kreport.com/methodology