Cleared Traditional

Midmark Smart M9? Sterilizer, Midmark Smart M11? Sterilizer

K233026 · Midmark Corporation · General Hospital
Apr 2024
Decision
195d
Days
Class 2
Risk

About This 510(k) Submission

K233026 is an FDA 510(k) clearance for the Midmark Smart M9? Sterilizer, Midmark Smart M11? Sterilizer, a Sterilizer, Steam (Class II — Special Controls, product code FLE), submitted by Midmark Corporation (Versailles, US). The FDA issued a Cleared decision on April 4, 2024, 195 days after receiving the submission on September 22, 2023. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6880.

Submission Details

510(k) Number K233026 FDA.gov
FDA Decision Cleared SESE
Date Received September 22, 2023
Decision Date April 04, 2024
Days to Decision 195 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code FLE — Sterilizer, Steam
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.6880

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