Cleared Traditional

VERIFY Spore Test Strip for S40 Sterilant Concentrate

K231746 · STERIS Corporation · General Hospital

Sep 2023

Decision

88d

Days

Class 2

Risk

About This 510(k) Submission

K231746 is an FDA 510(k) clearance for the VERIFY Spore Test Strip for S40 Sterilant Concentrate, 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 September 11, 2023, 88 days after receiving the submission on June 15, 2023. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6887.

Submission Details

510(k) Number	K231746 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 15, 2023
Decision Date	September 11, 2023
Days to Decision	88 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.