510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K043314Substantially Equivalent

Manzi Cleaner System

Langford IC Systems, Inc., Tucson AZ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K043314 is the FDA 510(k) clearance record for MANZI CLEANER SYSTEM, a class II device, cleared for Langford IC Systems, Inc. on under FDA product code NVE (Washer, Cleaner, Automated, Endoscope). FDA's definition for product code NVE reads: "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...". FDA records list 3 510(k) clearances for Langford IC Systems, Inc., from to . As of , FDA records show no recalls naming K043314.

Clearance record

Decision date
Received
(201 days to decision)
Product code
NVE Washer, Cleaner, Automated, Endoscope
Regulation
21 CFR 876.1500
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Langford IC Systems, Inc. 310 S. Williams Blvd., Tucson AZ
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NVE

Trailing 12 months

FDA records hold no clearances under product code NVE in the trailing twelve months.

FDA records show no clearances under product code NVE in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code NVE, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260