# K965086: Cygnus Electrosurgical Tip Cleaner

- Pathway: 510(k) (Traditional)
- Applicant: Madison Polymeric Engineering
- Decided: Feb 14, 1997 after 57 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 K803055 (1981). 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)
- K803055: Electrosurgical Tip Cleaner & Holder, Devon Industries, Inc. (1981) Summary page 1.

## Indications for use
The primary purpose of the device is to provide a convenient and effective surface for cleaning the tips of electrosurgical cutting and coagulation instruments. The design of the pad is such that the device may be used during surgery and in conjunction with the electrosurgical instrument.

Source page: https://510kreport.com/device/K965086
Methodology: https://510kreport.com/methodology