# K053433: Cautery Tip Cleaner, Model 30500

- Pathway: 510(k) (Traditional)
- Applicant: Xodus Medical, Inc.
- Decided: Jan 19, 2006 after 41 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
Longest line of descent: 1 generation back to K030339 (2003). 1 ancestor in all.
2 later devices descend from it; 1 cites 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)
- K030339: Cautery Tip Cleaner, Model-TC-100, Aspen Surgical Products, Inc. (2003) Summary page 1.

## Most influential descendants
- K151222: Cautery Tip Cleaner (2015), 1 descendant of its own
- K241022: Sterile single use tip  cleaner (WK800-S10 , WK800-S20) (2024), 0 descendants of its own

## Recalls of this device
- Sep 19, 2019 · Class II · Z-0150-2020: The sterile barrier of some devices may have been affected
- Sep 19, 2019 · Class II · Z-0151-2020: The sterile barrier of some devices may have been affected
- Sep 19, 2019 · Class II · Z-0149-2020: The sterile barrier of some devices may have been affected

## Indications for use
The disposable Cautcry Tip Cleaner is a single use sterile product. Its intended use is as an electrosurgical accessory to clean uncoated cautery blades that are part of an electrosurgical pencil. The cautery blade is "scratched" on the cautery tip cleaner to remove eschar build-up during surgical procedures to allow the cautery blade to function effectively throughout the procedure. The product is usually placed somewhere on the sterile field, typically on the mayo stand. This product does not come in contact with the patient.

Source page: https://510kreport.com/device/K053433
Methodology: https://510kreport.com/methodology