Cleared Traditional

SterilContainer S2 System

K193582 · Aesculap, Inc. · General Hospital

Mar 2020

Decision

85d

Days

Class 2

Risk

About This 510(k) Submission

K193582 is an FDA 510(k) clearance for the SterilContainer S2 System, 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 March 17, 2020, 85 days after receiving the submission on December 23, 2019. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6850.

Submission Details

510(k) Number	K193582 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 23, 2019
Decision Date	March 17, 2020
Days to Decision	85 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