Cleared Special

enspire 3000 Cleaning and Liquid Chemical Sterilant Processing System

K243433 · STERIS Corporation · General Hospital

Dec 2024

Decision

27d

Days

Class 2

Risk

About This 510(k) Submission

K243433 is an FDA 510(k) clearance for the enspire 3000 Cleaning and Liquid Chemical Sterilant Processing System, a Accessories, Cleaning, For Endoscope (Class II — Special Controls, product code FEB), submitted by STERIS Corporation (Mentor, US). The FDA issued a Cleared decision on December 2, 2024, 27 days after receiving the submission on November 5, 2024. This device falls under the General Hospital review panel. Regulated under 21 CFR 876.1500.

Submission Details

510(k) Number	K243433 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 05, 2024
Decision Date	December 02, 2024
Days to Decision	27 days
Submission Type	Special
Review Panel	General Hospital (HO)
Summary	Summary PDF

Device Classification

Product Code	FEB — Accessories, Cleaning, For Endoscope
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 876.1500
Definition	If The Device Is Reusable, Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission (82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).