510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K941163Substantially Equivalent

Mon-Klenz

Calgon Vestal Div., St. Louis MO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K941163 is the FDA 510(k) clearance record for MON-KLENZ, a class I device, cleared for Calgon Vestal Div. on under FDA product code FLG (Cleaner, Ultrasonic, Medical Instrument). FDA records list 19 510(k) clearances for Calgon Vestal Div., from to . As of , FDA records show no recalls naming K941163.

Clearance record

Decision date
Received
(68 days to decision)
Product code
FLG Cleaner, Ultrasonic, Medical Instrument
Regulation
21 CFR 880.6150
Device class
Class I
Review panel
General Hospital
Applicant
Calgon Vestal Div. P.O. Box 147, St. Louis MO
510(k) summary
Summary
Third party review
No

Clearances, product code FLG

Trailing 12 months

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

FDA records show no clearances under product code FLG in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code FLG, 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