Cleared Traditional

Aesculap AICON Container

K214041 · Aesculap, Inc. · General Hospital

Dec 2022

Decision

372d

Days

Class 2

Risk

About This 510(k) Submission

K214041 is an FDA 510(k) clearance for the Aesculap AICON Container, a Sterilization Wrap Containers, Trays, Cassettes & Other Accessories (Class II — Special Controls, product code KCT), submitted by Aesculap, Inc. (Center Valley, US). The FDA issued a Cleared decision on December 30, 2022, 372 days after receiving the submission on December 23, 2021. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6850.

Submission Details

510(k) Number	K214041 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 23, 2021
Decision Date	December 30, 2022
Days to Decision	372 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF

Device Classification

Product Code	KCT — Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 880.6850