Cleared Traditional

VERIFY STEAM Integrating Indicator, VERIFY STEAM Integrating Indicator 5CM

K213412 · Steris Corparation · General Hospital

Jan 2022

Decision

94d

Days

Class 2

Risk

About This 510(k) Submission

K213412 is an FDA 510(k) clearance for the VERIFY STEAM Integrating Indicator, VERIFY STEAM Integrating Indicator 5CM, a Indicator, Physical/chemical Sterilization Process (Class II — Special Controls, product code JOJ), submitted by Steris Corparation (Mentor, US). The FDA issued a Cleared decision on January 21, 2022, 94 days after receiving the submission on October 19, 2021. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.2800.

Submission Details

510(k) Number	K213412 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 19, 2021
Decision Date	January 21, 2022
Days to Decision	94 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF