510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K042457Substantially Equivalent

Uro Pro

Novanta Medical GmbH, Hingham MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K042457 is the FDA 510(k) clearance record for URO PRO, a class II device, cleared for W.O.M. World of Medicine AG on under FDA product code LJH (System, Irrigation, Urological). FDA records list 41 510(k) clearances for Novanta Medical GmbH, from to . As of , FDA records show one recall naming K042457.

Clearance record

Decision date
Received
(45 days to decision)
Product code
LJH System, Irrigation, Urological
Regulation
21 CFR 876.5130
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
W.O.M. World of Medicine AG 119 S. St., Hingham MA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code LJH

Trailing 12 months
1 clearance under product code LJH in the twelve months to October 2026, September 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code LJH, 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 20261
October 20260