510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K173590Substantially Equivalent

System 83 Plus Washer/Disinfector

Wassenburg Medical B.V., Ivyland PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K173590 is the FDA 510(k) clearance record for System 83 Plus Washer/Disinfector, a class II device, cleared for Custom Ultrasonics, Inc. on under FDA product code FEB (Accessories, Cleaning, For Endoscope). FDA's definition for product code FEB reads: "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...". FDA records list 7 510(k) clearances for WASSENBURG MEDICAL B.V., from to . As of , FDA records show no recalls naming K173590.

Clearance record

Decision date
Received
(860 days to decision)
Product code
FEB Accessories, Cleaning, For Endoscope
Regulation
21 CFR 876.1500
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Custom Ultrasonics, Inc. 144 Railroad Dr., Ivyland PA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code FEB

Trailing 12 months

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

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