Cleared Traditional

enspire 300 Series Automated Endoscope Reprocessor System

K230560 · STERIS Corporation · General Hospital

Jul 2023

Decision

143d

Days

Class 2

Risk

About This 510(k) Submission

K230560 is an FDA 510(k) clearance for the enspire 300 Series Automated Endoscope Reprocessor System, a Accessories, Germicide, Cleaning, For Endoscopes (Class II — Special Controls, product code NZA), submitted by STERIS Corporation (Mentor, US). The FDA issued a Cleared decision on July 21, 2023, 143 days after receiving the submission on February 28, 2023. This device falls under the General Hospital review panel. Regulated under 21 CFR 876.1500.

Submission Details

510(k) Number	K230560 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 28, 2023
Decision Date	July 21, 2023
Days to Decision	143 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF

Device Classification

Product Code	NZA — Accessories, Germicide, Cleaning, For Endoscopes
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 876.1500
Definition	High Level Disinfection Of Reusable, Heat-sensitive Devices 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).