Cleared Traditional

SterilContainer S System

K182032 · Aesculap, Inc. · General Hospital

Dec 2018

Decision

144d

Days

Class 2

Risk

About This 510(k) Submission

K182032 is an FDA 510(k) clearance for the SterilContainer S 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 December 21, 2018, 144 days after receiving the submission on July 30, 2018. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6850.

Submission Details

510(k) Number	K182032 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 30, 2018
Decision Date	December 21, 2018
Days to Decision	144 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