# K971805: Electrosurgical Tip Cleaner, Tip Cleaning Pad, Lectrobrasive Tip Cleaner, Electrosurgical Tip Cleaner, Electrode Tip Cle

- Pathway: 510(k) (Traditional)
- Applicant: Aaron Medical Industries
- Decided: Jun 13, 1997 after 29 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.
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’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The subject device of this premarket notification submission is indicated for use as an electrosurgical accessory for removal by scraping of eschar build up on the electrosurgical electrode. This product is designed for use with all stainless steel electrodes and is not indicated for use with coated stick electrodes.

Source page: https://510kreport.com/device/K971805
Methodology: https://510kreport.com/methodology