PlumeSafe X5 Smoke Management System
K-Number: K240127 · 2024-08-05
ApplicantConmed Corporation
Decision Date2024-08-05
Product CodeFYD
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
PlumeSafe X5 Smoke Management System is a medical device manufactured by Conmed Corporation. It received FDA 510(k) clearance on 2024-08-05 under approval number K240127. The device is classified under product code FYD. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the PlumeSafe X5 Smoke Management System?
PlumeSafe X5 Smoke Management System is a medical device that received FDA 510(k) clearance on 2024-08-05. It is manufactured by Conmed Corporation. The 510(k) number is K240127.
When was PlumeSafe X5 Smoke Management System approved by the FDA?
PlumeSafe X5 Smoke Management System received FDA 510(k) clearance on 2024-08-05, under approval number K240127.
What company makes PlumeSafe X5 Smoke Management System?
PlumeSafe X5 Smoke Management System is manufactured by Conmed Corporation.
What is the FDA product code for PlumeSafe X5 Smoke Management System?
The FDA product code for PlumeSafe X5 Smoke Management System is FYD.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.