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.
| 510(k) Number | K240127 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 17, 2024 |
| Decision Date | August 05, 2024 |
| Days to Decision | 201 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FYD — Apparatus, Exhaust, Surgical |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.5070 |