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510(k) K043314

MANZI CLEANER SYSTEM by Langford IC Systems, Inc. — Product Code NVE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 20, 2005
Date Received
December 1, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Washer, Cleaner, Automated, Endoscope
Device Class
Class II
Regulation Number
876.1500
Review Panel
HO
Submission Type

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.

Other clearances by Langford IC Systems, Inc.

  • K101158 — LIC INSTRUMENT PROCESSING SYSTEM (May 6, 2011)
  • K060458 — MANZI MACH 1 INSTRUMENT CLEANER-PROCESSOR SYSTEM, MANZI DETERGENT MD10, MANZI ST (October 12, 2006)

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