PlumeSafe X5 Smoke Management System
FDA 510(k) K240127 · Conmed Corporation
510(k) numberK240127
Submission
- Device name
- PlumeSafe X5 Smoke Management System
- Applicant
- Conmed Corporation
Greenwood Village, CO, US - Received
- January 17, 2024
- Decision date
- August 5, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FYD – Apparatus, Exhaust, Surgical
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.5070
- Specialty
- General, Plastic Surgery
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Questions and answers
When was PlumeSafe X5 Smoke Management System cleared by the FDA?
PlumeSafe X5 Smoke Management System (K240127) received a 510(k) decision of Substantially Equivalent on August 5, 2024, 201 days after the submission was received.
What is the product code of K240127?
The FDA product code is FYD – Apparatus, Exhaust, Surgical, a Class II (moderate risk) device regulated under 21 CFR 878.5070.