Cleared Traditional

K040865 - AESCULAP STERRAD 100S COMPATABLE STERILCONTAINER
(FDA 510(k) Clearance)

K040865 · Aesculap · General Hospital

Dec 2004

Decision

248d

Days

Class 2

Risk

K040865 is an FDA 510(k) clearance for the AESCULAP STERRAD 100S COMPATABLE STERILCONTAINER. This device is classified as a Wrap, Sterilization (Class II — Special Controls, product code FRG).

Submitted by Aesculap (Center Valley, US). The FDA issued a Cleared decision on December 6, 2004, 248 days after receiving the submission on April 2, 2004.

This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6850.

Submission Details

510(k) Number	K040865 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 02, 2004
Decision Date	December 06, 2004
Days to Decision	248 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF