# K030339: Cautery Tip Cleaner, Model-TC-100

- Pathway: 510(k) (Traditional)
- Applicant: Aspen Surgical Products, Inc.
- Decided: Mar 7, 2003 after 35 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; 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)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K053433: Cautery Tip Cleaner, Model 30500 (2006), 2 descendants of its own
- 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

## Indications for use
The disposable Cautery Tip Cleaner is a single use sterile product. It is intended to be used as an electrosurgical accessory. The Cautery Tip Cleaner provides a method of removing eschar build-up from the tip of electro surgical instruments during the course of a surgical procedure.

Source page: https://510kreport.com/device/K030339
Methodology: https://510kreport.com/methodology