510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K961982Substantially Equivalent

Tri-Flow Three Way Stopcock

North, Inc., Northfield MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K961982 is the FDA 510(k) clearance record for TRI-FLOW THREE WAY STOPCOCK, a class II device, cleared for North, Inc. on under FDA product code FMG (Stopcock, I.V. Set). FDA records list 2 510(k) clearances for North, Inc., from to . As of , FDA records show no recalls naming K961982.

Clearance record

Decision date
Received
(277 days to decision)
Product code
FMG Stopcock, I.V. Set
Regulation
21 CFR 880.5440
Device class
Class II
Review panel
General Hospital
Applicant
North, Inc. 303 Washington, Suite B, Northfield MN
510(k) summary
Summary
Third party review
No

Clearances, product code FMG

Trailing 12 months

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

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