Cleared Traditional

K192978 - EOGas 4 Ethylene Oxide Gas Sterilizer
(FDA 510(k) Clearance)

K192978 · Andersen Sterilizers, Inc. · General Hospital

Nov 2020

Decision

385d

Days

Class 2

Risk

K192978 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 12, 2020, 385 days after receiving the submission on October 24, 2019.

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

Submission Details

510(k) Number	K192978 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 24, 2019
Decision Date	November 12, 2020
Days to Decision	385 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF