# K241022: Sterile single use tip  cleaner (WK800-S10 , WK800-S20)

- Pathway: 510(k) (Traditional)
- Applicant: Wickimed (Huizhou) Medical Equipment Manufacturing Co.,Ltd
- Decided: Jul 11, 2024 after 87 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: 3 generations back to K030339 (2003). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151222: Cautery Tip Cleaner, Key Surgical, Inc. (2015) Summary page 5.

## Indications for use
The sterile single use tip cleaner is a single use sterile device intended to be used as an electrosurgical accessory to remove eschar buildup from the tips of electrosurgical cauterization blades during surgical procedures.

Source page: https://510kreport.com/device/K241022
Methodology: https://510kreport.com/methodology