Cleared Traditional

K170432 - Anprolene AN75 Ethylene Oxide Gas Sterilizer
(FDA 510(k) Clearance)

K170432 · Andersen Sterilizers, Inc. · General Hospital

Oct 2017

Decision

260d

Days

Class 2

Risk

K170432 is an FDA 510(k) clearance for the Anprolene AN75 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 October 31, 2017, 260 days after receiving the submission on February 13, 2017.

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

Submission Details

510(k) Number	K170432 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 13, 2017
Decision Date	October 31, 2017
Days to Decision	260 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF