FDA 510(k)

PlumeSafe X5 Smoke Management System

K-Number: K240127 · 2024-08-05

Decision Date2024-08-05

Product CodeFYD

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

PlumeSafe X5 Smoke Management System is the device name listed in this FDA 510(k) record. The listed applicant is Conmed Corporation. It received FDA 510(k) clearance on 2024-08-05 under 510(k) 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. The listed applicant is Conmed Corporation. The 510(k) number is K240127.

When did PlumeSafe X5 Smoke Management System receive FDA 510(k) clearance?

PlumeSafe X5 Smoke Management System received FDA 510(k) clearance on 2024-08-05, under 510(k) number K240127.

Who is the listed applicant for PlumeSafe X5 Smoke Management System?

The FDA 510(k) record lists Conmed Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PlumeSafe X5 Smoke Management System?

The FDA product code for PlumeSafe X5 Smoke Management System is FYD.

Other records listing Conmed Corporation as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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.