Cleared Special

AMSCO 600 Steam Sterilizer

K232485 · Steris · General Hospital
Sep 2023
Decision
28d
Days
Class 2
Risk

About This 510(k) Submission

K232485 is an FDA 510(k) clearance for the AMSCO 600 Steam Sterilizer, a Sterilizer, Steam (Class II — Special Controls, product code FLE), submitted by Steris (Mentor, US). The FDA issued a Cleared decision on September 13, 2023, 28 days after receiving the submission on August 16, 2023. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6880.

Submission Details

510(k) Number K232485 FDA.gov
FDA Decision Cleared SESE
Date Received August 16, 2023
Decision Date September 13, 2023
Days to Decision 28 days
Submission Type Special
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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