Submission Details
| 510(k) Number | K213068 FDA.gov |
| FDA Decision | Cleared 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 |
Cleared
Traditional
Medline Smoke Evacuation Shroud
Jan 2022
Decision
102d
Days
Class 2
Risk
About This 510(k) Submission
K213068 is an FDA 510(k) clearance for the Medline Smoke Evacuation Shroud, a Apparatus, Exhaust, Surgical (Class II — Special Controls, product code FYD), submitted by Medline Industries, Inc. (Nortfield, 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 review panel. Regulated under 21 CFR 878.5070.
Device Classification
| Product Code | FYD — Apparatus, Exhaust, Surgical |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 878.5070 |
Manufacturer
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