K240127 - PlumeSafe X5 Smoke Management System
(FDA 510(k) Clearance)

K240127 is an FDA 510(k) clearance for the PlumeSafe X5 Smoke Management System. This device is classified as a Apparatus, Exhaust, Surgical (Class II — Special Controls, product code FYD).

Submitted by Conmed Corporation (Greenwood Village, US). The FDA issued a Cleared decision on August 5, 2024, 201 days after receiving the submission on January 17, 2024.

This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.5070.