FDA 510(k) Applications for Medical Device Product Code: FMG (Stopcock, I.V. Set)

FDA 510(k) Applications for Medical Device Product Code "FMG"
(Stopcock, I.V. Set)

FDA 510(k) Number	Applicant	Device Name	Decision Date
K130245	BAXTER HEALTHCARE CORP.	LARGE BORE STOPCOCK WITH ROTATING MALE LUER LOCK/LARGE BORE STOPCOCK WITH EXTENSION SET, GANG LARGE BORE STOPCOCK MANIFO	03/01/2013
K962581	BAXTER HEALTHCARE CORP.	STOPCOCK MANIFOLD GANGS	08/28/1996
K223175	Baxter Healthcare Corporation	lntravascular Administration Sets with Stopcock and Manifold	03/10/2023
K071400	CARDINAL HEALTH, ALARIS PRODUCTS	SMARTSITE STOPCOCK	12/14/2007
K012157	CHURCHILL MEDICAL SYSTEMS, INC.	CHURCHILL MEDICAL SYSTEMS STOPCOCK	09/11/2001
K954984	DISTRONIC STERILE PRODUCTS, INC.	MINIBORE STOPCOCK SET	01/23/1996
K172266	Dynarex Corporation	Dynarex Three-Way Stopcock	03/14/2018
K053405	ELCAM MEDICAL A.C.A.L.	BACSTOP	05/11/2006
K060231	ELCAM MEDICAL A.C.A.L.	CLOSED SWABABLE STOPCOCK AND MINIMAL RESIDUAL VOLUME LUER-ACTIVATED SWABABLE-STOPCOCK	04/13/2006
K123084	ELCAM MEDICAL A.C.A.L.	DISPOSABLE HIGH PRESSURE STOPCOCK/MANIFOLD MODEL HP STOPCOCK, MP STOPCOCK, HP MANIFOLD, PHP MANIFOLD	05/23/2013
K082106	ELCAM MEDICAL A.C.A.L.	ELCAM ANTIMICROBIAL CLOSED STOPCOCKS (DSS AND TSS)	10/02/2008
K190489	Elcam Medical ACAL	Elcam Stopcocks and Manifolds	04/23/2019
K141254	ELCAM MEDICAL ACAL	ELCAM STOPCOCKS AND MANIFOLDS	07/30/2014
K032393	ELCAM MEDICAL ACAL	INDUCTION AND SAMPLING MANIFOLD (OR STOPCOCK)	09/12/2003
K211204	Elcam Medical ACAL	SafePort(TM) Manifold (or Stopcock)	09/15/2022
K010217	GEORGE LOO, MD	4 PORT, 4 WAY STOPCOCK	03/18/2001
K061143	HALKEY-ROBERTS CORP.	ROBERTSITE STOPCOCK	05/10/2006
K080077	ICU MEDICAL, INC	CLAVE STOPCOCK	02/13/2008
K082836	ICU MEDICAL, INC.	ICU MEDICAL UNIVERSAL SINGLE-USE SPIKES	02/25/2009
K964435	ICU MEDICAL, INC.	PRIMARY IV SET	04/02/1997
K982368	INTERPORE CROSS INTL.	MANIFOLD WITH EXTENSION SET	07/31/1998
K070143	JMS NORTH AMERICA CORP.	JMS PLANECTA STOPCOCK	04/10/2007
K223499	M/s Romsons International	Three Way Stop Cock	07/21/2023
K052330	MEDEGEN MEDICAL MANUFACTURING SERVICES	TRU-SWAB STOCOCK	09/09/2005
K954970	MEDEX, INC.	STOPCOCK & LUER LOCK PLUG	04/22/1996
K022895	MEDICAL DEVICE CONSULTANTS, INC.	ELCAM STOPCOCKS AND MANIFOLDS	10/18/2002
K955782	MEDNET, INC.	MED-NET STOPCOCKS	02/21/1996
K190539	MonuMedical, LLC	TurnSignal Stopcocks Sterile, TurnSignal Stopcocks Buld Non Sterile, TurnSignal Stopcocks with Manifolds Sterile, TurnSignal Stopcocks with Manifolds Bulk Non Sterile	10/22/2019
K041779	NIPRO MEDICAL CORP.	NIPRO DISPOSABLE STOPCOCKS, MODELS 3W-RC. NCN-3, 3W-R, 3W-L	09/21/2004
K961982	NORTH, INC.	TRI-FLOW THREE WAY STOPCOCK	02/21/1997
K974083	OHMEDA MEDICAL	CONNECTA PLUS 1 AND CONNECTA PLUS 3 2-WAY AND 3-WAY STOPCOCKS	01/13/1998
K082110	SURGIN SURGICAL INSTRUMENTATION, INC.	DUAL SYRINGE HOLDER	06/17/2009
K210516	Yomura Technologies Inc.	Clicky Cross	05/16/2022

FDA 510(k) Applications for Medical Device Product Code "FMG" (Stopcock, I.V. Set)

FDA 510(k) Applications for Medical Device Product Code "FMG"
(Stopcock, I.V. Set)