K213068 is an FDA 510(k) clearance for the Medline Smoke Evacuation Shroud. This device is classified as a Apparatus, Exhaust, Surgical (Class II - Special Controls, product code FYD).
Submitted by Medline Industries, Inc. (Northfiled, US). The FDA issued a Cleared decision on January 3, 2022, 102 days after receiving the submission on September 23, 2021.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.5070.
| 510(k) Number | K213068 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 23, 2021 |
| Decision Date | January 03, 2022 |
| Days to Decision | 102 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Statement |
| Product Code | FYD — Apparatus, Exhaust, Surgical |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.5070 |