Aesculap® SterilContainer(TM) S2 System

Sterilization Wrap Containers, Trays, Cassettes & Other Accessories

Aesculap, Inc.

The following data is part of a premarket notification filed by Aesculap, Inc. with the FDA for Aesculap® Sterilcontainer(tm) S2 System.

Pre-market Notification Details

• Device ID: K182414
• 510k Number: K182414
• Device Name: Aesculap® SterilContainer(TM) S2 System
• Classification: Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
• Applicant: Aesculap, Inc. 3773 Corporate Parkway Center Valley, PA 18034
• Contact: Sierra Mertz
• Correspondent: Sierra Mertz; Aesculap, Inc. 3773 Corporate Parkway Center Valley, PA 18034
• Product Code: KCT
• CFR Regulation Number: 880.6850 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2018-09-04
• Decision Date: 2019-07-05