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 Surnic Corporation.
FDA 510(k) Cleared Apparatus, Exhaust, Surgical Devices (Product Code FYD)
About Product Code FYD - Regulatory Context
510(k) Submission Activity
75 total 510(k) submissions under product code FYD since 1985, with 75 receiving FDA clearance (average review time: 194 days).
Submission volume has remained relatively stable over the observed period, with 1 submissions in the last 24 months.
FDA Review Time
FDA review times for FYD submissions have been consistent, averaging 201 days recently vs 194 days historically.
FYD devices are reviewed by the General Hospital panel. Browse all General Hospital devices →