# K030158: Unit, Cautery, Tehrmal,Battery-Powered

- Pathway: 510(k) (Traditional)
- Applicant: Walsh Medical Devices, Inc.
- Decided: Jul 17, 2003 after 182 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 K945762 (1995). 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)
- K945761: Low Temperature Cautery Fine Tip, Adjustable, Replaceable Tip, Aaron Medical Industries (1995) Summary page 1.
- K945762: Low Temperature Cautery Fine Tip, Adjustable, Aaron Medical Industries (1995) Summary page 1.
- K945763: Low Temperature Cautery Elongated Fine Tip, Aaron Medical Industries (1995) Summary page 1.

## Indications for use
CAUTERY HANDLES AND CAUTERY TIPS ARE INTENDED FOR COAGULATING TISSUE OR ARRESTING BLEEDING FROM SMALL. VESSELS USING HEAT CREATED BY THE WIRE TIP. INDICATIONS INCLUDE OPHTHALMIC AND GENERAL AND PLASTIC SURGERY PROCEDURES.

Source page: https://510kreport.com/device/K030158
Methodology: https://510kreport.com/methodology