510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K842754Substantially Equivalent

Custom Ultrasonics-Sys 80, 81-24, 83-2

Wassenburg Medical B.V., Buckingham PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K842754 is the FDA 510(k) clearance record for CUSTOM ULTRASONICS-SYS 80, 81-24, 83-2, a class I device, cleared for Custom Ultrasonics on under FDA product code FLG (Cleaner, Ultrasonic, Medical Instrument). FDA records list 7 510(k) clearances for WASSENBURG MEDICAL B.V., from to . As of , FDA records show no recalls naming K842754.

Clearance record

Decision date
Received
(135 days to decision)
Product code
FLG Cleaner, Ultrasonic, Medical Instrument
Regulation
21 CFR 880.6150
Device class
Class I
Review panel
General Hospital
Applicant
Custom Ultrasonics P.O. Box 850, Buckingham PA
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