# K971758: Cauterization Smoke Evacuator

- Pathway: 510(k) (Traditional)
- Applicant: Applied Medical Technologies
- Decided: Jul 21, 1997 after 69 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.
No later device cites it as a predicate yet.
0 of 1 device 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.

## Indications for use
The Cauterization Smoke Evacuator is an accessory device used to provide an air suction path for the reduction of gasses, body fluids, and smoke associated with the use of most electro-cauterization systems. The Cauterization Smoke Evacuator is meant to be an accessory add-on device to currently designed and distributed electro-cauterization systems, and most standard operating room suction systems.

Source page: https://510kreport.com/device/K971758
Methodology: https://510kreport.com/methodology