FYD · Class II · 21 CFR 878.5070

FDA Product Code FYD: Apparatus, Exhaust, Surgical

Smoke evacuation in the operating room protects surgical team members from toxic surgical plume. FDA product code FYD covers surgical exhaust apparatus used to capture and filter electrosurgical and laser smoke.

These devices use suction and filtration to capture surgical plume at the source, preventing inhalation of particulates, viable cellular material, and toxic chemicals released during electrosurgery, laser procedures, and powered bone cutting.

FYD devices are Class II medical devices, regulated under 21 CFR 878.5070 and reviewed by the FDA General Hospital panel.

Leading manufacturers include Northgate Technologies, Inc., Medline Industries, Inc. and Conmed Corporation.

3
Total
3
Cleared
160d
Avg days
2021
Since

List of Apparatus, Exhaust, Surgical devices cleared through 510(k)

3 devices
1–3 of 3
Cleared Aug 05, 2024
PlumeSafe X5 Smoke Management System
K240127
Conmed Corporation
General Hospital · 201d
Cleared Jan 03, 2022
Medline Smoke Evacuation Shroud
K213068
Medline Industries, Inc.
General Hospital · 102d
Cleared Mar 25, 2021
NEBULAE SRS Laparoscopic Surgical Smoke Removal System
K202944
Northgate Technologies, Inc.
General Hospital · 176d

How to use this database

This page lists all FDA 510(k) submissions for Apparatus, Exhaust, Surgical devices (product code FYD). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.

These devices fall under the General Hospital FDA review panel. Browse all General Hospital devices →