510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K001325Substantially Equivalent

Flo Assistant, Model 4-250-00

Northgate Technologies Inc., Elgin IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K001325 is the FDA 510(k) clearance record for FLO ASSISTANT, MODEL 4-250-00, a class II device, cleared for Northgate Technologies, Inc. on under FDA product code LJH (System, Irrigation, Urological). FDA records list 55 510(k) clearances for Northgate Technologies, Inc., from to . As of , FDA records show no recalls naming K001325.

Clearance record

Decision date
Received
(114 days to decision)
Product code
LJH System, Irrigation, Urological
Regulation
21 CFR 876.5130
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Northgate Technologies, Inc. 600 Church Rd., Elgin IL
510(k) summary
Summary
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