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510(k) K190539

Device
TurnSignal Stopcocks Sterile, TurnSignal Stopcocks Buld Non Sterile, TurnSignal Stopcocks With Manifolds Sterile, TurnSignal Stopcocks With Manifolds Bulk Non Sterile
Applicant
MonuMedical, LLC
510(k) number
K190539
Product code
FMG  
Decision
Substantially Equivalent (SESE)
Decision date
2019-10-22
Date received
2019-03-04
Regulation
880.5440
Classification name
Stopcock, I.v. Set
Medical specialty
General Hospital
Review panel
General Hospital
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
John Knapik
Address
3017 Douglas Blvd., Suite 300 Roseville CA US 95661 95661

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code FMG  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K242255Qitexio® 4-Way Stopcock (QIT014)Medex2025-04-29
K223499Three Way Stop CockM/S Romsons International2023-07-21
K223175lntravascular Administration Sets with Stopcock and ManifoldBaxter Healthcare Corporation2023-03-10
K211204SafePort(TM) Manifold (or Stopcock)Elcam Medical Acal2022-09-15
K210516Clicky CrossYomura Technologies, Inc.2022-05-16
K190489Elcam Stopcocks and ManifoldsElcam Medical Acal2019-04-23
K172266Dynarex Three-Way StopcockDynarex Corporation2018-03-14
K141254ELCAM STOPCOCKS AND MANIFOLDSElcam Medical Acal2014-07-30
K123084DISPOSABLE HIGH PRESSURE STOPCOCK/MANIFOLD MODEL HP STOPCOCK, MP STOPCOCK, HP MANIFOLD, PHP MANIFOLDElcam Medical Acal2013-05-23
K130245LARGE BORE STOPCOCK WITH ROTATING MALE LUER LOCK/LARGE BORE STOPCOCK WITH EXTENSION SET, GANG LARGE BORE STOPCOCK MANIFOBaxter Healthcare Corp2013-03-01
K082110DUAL SYRINGE HOLDERSurgin Surgical Instrumentation, Inc.2009-06-17
K082836ICU MEDICAL UNIVERSAL SINGLE-USE SPIKESIcu Medical, Inc.2009-02-25
K082106ELCAM ANTIMICROBIAL CLOSED STOPCOCKS (DSS AND TSS)Elcam Medical Acal2008-10-02
K080077CLAVE STOPCOCKIcu Medical, Inc.2008-02-13
K071400SMARTSITE STOPCOCKCardinal Health, Alaris Products2007-12-14

Legacy Summary#

summary

FDA Review#

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