Cleared Traditional

K150646 - EOGas 4 Ethylene Oxide Gas Sterilizer
(FDA 510(k) Clearance)

K150646 · Andersen Sterilizers, Inc. · General Hospital

Nov 2015

Decision

251d

Days

Class 2

Risk

K150646 is an FDA 510(k) clearance for the EOGas 4 Ethylene Oxide Gas Sterilizer. This device is classified as a Sterilizer, Ethylene-oxide Gas (Class II — Special Controls, product code FLF).

Submitted by Andersen Sterilizers, Inc. (Haw River, US). The FDA issued a Cleared decision on November 18, 2015, 251 days after receiving the submission on March 12, 2015.

This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6860.

Submission Details

510(k) Number	K150646 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 12, 2015
Decision Date	November 18, 2015
Days to Decision	251 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF