Cleared Traditional

MANZI CLEANER SYSTEM

K043314 · Langford IC Systems, Inc. · General Hospital

Jun 2005

Decision

201d

Days

Class 2

Risk

About This 510(k) Submission

K043314 is an FDA 510(k) clearance for the MANZI CLEANER SYSTEM, a Washer, Cleaner, Automated, Endoscope (Class II — Special Controls, product code NVE), submitted by Langford IC Systems, Inc. (Tucson, US). The FDA issued a Cleared decision on June 20, 2005, 201 days after receiving the submission on December 1, 2004. This device falls under the General Hospital review panel. Regulated under 21 CFR 876.1500.

Submission Details

510(k) Number	K043314 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 01, 2004
Decision Date	June 20, 2005
Days to Decision	201 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF

Device Classification

Product Code	NVE — Washer, Cleaner, Automated, Endoscope
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 876.1500
Definition	This Automated Device Is Intended To Be Used To Clean Endoscopes. Endoscopes That Are Intended To Be Cleaned By The Automated Cleaner System Should Have Been Pre-cleaned And Tested For Leaks And Lumen Obstructions According To The Instrument Manufacturer's Instructions And Current Professional Practices Prior To Processing In The System. The System Includes A Chemical Dispensing System That Meters Out A Predetermined Volume Of Detergent During The Appropriate Cleaning Cycle. 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). The Instrument Is Placed In A Tray With Each Lumen End Positioned In Opposite Sides Of The Tray To Allow Enough Detergent And Rinsing Water Pass Through The Lumens Of The Endoscopes.