Cleared Traditional

VERIFY Spore Test Strip for S40 Sterilant

K180553 · STERIS Corporation · General Hospital

May 2018

Decision

89d

Days

Class 2

Risk

About This 510(k) Submission

K180553 is an FDA 510(k) clearance for the VERIFY Spore Test Strip for S40 Sterilant, a Liquid Chemical Processing System (Class II — Special Controls, product code OVY), submitted by STERIS Corporation (Mentor, US). The FDA issued a Cleared decision on May 29, 2018, 89 days after receiving the submission on March 1, 2018. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6887.

Submission Details

510(k) Number	K180553 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 01, 2018
Decision Date	May 29, 2018
Days to Decision	89 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF

Device Classification

Product Code	OVY — Liquid Chemical Processing System
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 880.6887
Definition	The Liquid Chemical Processing System Is Intended As A Standard Method For Routine Monitoring.