Cleared Traditional

SteroScope? Sterilization Technology System

K233762 · Ideate Medical, Inc. · General Hospital
Jun 2024
Decision
216d
Days
Class 2
Risk

About This 510(k) Submission

K233762 is an FDA 510(k) clearance for the SteroScope? Sterilization Technology System, a Sterilizer, Chemical (Class II — Special Controls, product code MLR), submitted by Ideate Medical, Inc. (St. Louis, US). The FDA issued a Cleared decision on June 27, 2024, 216 days after receiving the submission on November 24, 2023. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6860.

Submission Details

510(k) Number K233762 FDA.gov
FDA Decision Cleared SESE
Date Received November 24, 2023
Decision Date June 27, 2024
Days to Decision 216 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code MLR — Sterilizer, Chemical
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.6860

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