Cleared Special

enspire 300 Series Automated Endoscope Reprocessor

K232918 · STERIS Corporation · General Hospital

Oct 2023

Decision

14d

Days

Class 2

Risk

About This 510(k) Submission

K232918 is an FDA 510(k) clearance for the enspire 300 Series Automated Endoscope Reprocessor, 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 October 3, 2023, 14 days after receiving the submission on September 19, 2023. This device falls under the General Hospital review panel. Regulated under 21 CFR 876.1500.

Submission Details

510(k) Number	K232918 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 19, 2023
Decision Date	October 03, 2023
Days to Decision	14 days
Submission Type	Special
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).