510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K010122Substantially Equivalent

Continuous Flow Y-Tubing

G.U.-Tek, South Plainfield NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K010122 is the FDA 510(k) clearance record for CONTINUOUS FLOW Y-TUBING, a class II device, cleared for G.U.-Tek on under FDA product code LJH (System, Irrigation, Urological). FDA records list one 510(k) clearance for G.U.-Tek. As of , FDA records show no recalls naming K010122.

Clearance record

Decision date
Received
(139 days to decision)
Product code
LJH System, Irrigation, Urological
Regulation
21 CFR 876.5130
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
G.U.-Tek 904 Oak Tree Ave., South Plainfield NJ
510(k) summary
Statement
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