# K991167: Steris Smoke Evacuation System

- Pathway: 510(k) (Abbreviated)
- Applicant: STERIS Corporation
- Decided: Jun 3, 1999 after 57 days
- Product code: FYD (Apparatus, Exhaust, Surgical)
- Device class: 2
- Regulation: 21 CFR 878.5070
- 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 STERIS Smoke Evacuation System will be used to evacuate the smoke plume created by electrosurgery, laser surgery, or power tool procedures. Locations for use include the OR, Trauma, Endoscopy and Laparoscopy Suites.

Source page: https://510kreport.com/device/K991167
Methodology: https://510kreport.com/methodology