Medline Smoke Evacuation Shroud
FDA 510(k) K213068 · Medline Industries, Inc.
510(k) numberK213068
Submission
- Device name
- Medline Smoke Evacuation Shroud
- Applicant
- Medline Industries, Inc.
Northfiled, IL, US - Received
- September 23, 2021
- Decision date
- January 3, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 Medline Smoke Evacuation Shroud cleared by the FDA?
Medline Smoke Evacuation Shroud (K213068) received a 510(k) decision of Substantially Equivalent on January 3, 2022, 102 days after the submission was received.
What is the product code of K213068?
The FDA product code is FYD – Apparatus, Exhaust, Surgical, a Class II (moderate risk) device regulated under 21 CFR 878.5070.