Cleared Traditional

Aesculap? SterilContainer(TM) S2 System

K182414 · Aesculap, Inc. · General Hospital

Jul 2019

Decision

304d

Days

Class 2

Risk

About This 510(k) Submission

K182414 is an FDA 510(k) clearance for the Aesculap? SterilContainer(TM) 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 July 5, 2019, 304 days after receiving the submission on September 4, 2018. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6850.

Submission Details

510(k) Number	K182414 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 04, 2018
Decision Date	July 05, 2019
Days to Decision	304 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