Panels › General Hospital › Product code FMG · Class 2
Stopcock, I.V. Set
Regulation 880.5440
0510(k)s in 12 months (89 all time)
19recalls in 12 months (207 all time)
204recalls that name a 510(k)
Top companies in FMG
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 29, 2025 | K242255 | Qitexio® 4-Way Stopcock (QIT014) Medex, FR | FMG |
| Jul 21, 2023 | K223499 | Three Way Stop Cock M/S Romsons International, IN | FMG |
| Mar 10, 2023 | K223175 | lntravascular Administration Sets with Stopcock and Manifold Baxter Healthcare Corporation | FMG |
| Sep 15, 2022 | K211204 | SafePort(TM) Manifold (or Stopcock) Elcam Medical Acal, IL | FMG |
| May 16, 2022 | K210516 | Clicky Cross Yomura Technologies, Inc., TW | FMG |
| Oct 22, 2019 | K190539 | TurnSignal Stopcocks Sterile, TurnSignal Stopcocks Buld Non Sterile, TurnSignal Stopcocks with Manifolds Sterile, TurnSi Monumedical, LLC | FMG |
| Apr 23, 2019 | K190489 | Elcam Stopcocks and Manifolds Elcam Medical Acal, IL | FMG |
| Mar 14, 2018 | K172266 | Dynarex Three-Way Stopcock Dynarex Corporation | FMG |
| Jul 30, 2014 | K141254 | ELCAM STOPCOCKS AND MANIFOLDS Elcam Medical Acal, IL | FMG |
| May 23, 2013 | K123084 | DISPOSABLE HIGH PRESSURE STOPCOCK/MANIFOLD MODEL HP STOPCOCK, MP STOPCOCK, HP MANIFOLD, PHP MANIFOLD Elcam Medical Acal, IL | FMG |
| Mar 1, 2013 | K130245 | LARGE BORE STOPCOCK WITH ROTATING MALE LUER LOCK/LARGE BORE STOPCOCK WITH EXTENSION SET, GANG LARGE BORE STOPCOCK MANIFO Baxter Healthcare Corp | FMG |
| Jun 17, 2009 | K082110 | DUAL SYRINGE HOLDER Surgin Surgical Instrumentation, Inc. | FMG |
| Feb 25, 2009 | K082836 | ICU MEDICAL UNIVERSAL SINGLE-USE SPIKES Icu Medical, Inc. | FMG |
| Oct 2, 2008 | K082106 | ELCAM ANTIMICROBIAL CLOSED STOPCOCKS (DSS AND TSS) Elcam Medical Acal, IL | FMG |
| Feb 13, 2008 | K080077 | CLAVE STOPCOCK Icu Medical, Inc. | FMG |
| Dec 14, 2007 | K071400 | SMARTSITE STOPCOCK Cardinal Health, Alaris Products | FMG |
| Apr 10, 2007 | K070143 | JMS PLANECTA STOPCOCK Jms North America Corp. | FMG |
| May 11, 2006 | K053405 | BACSTOP Elcam Medical Acal, IL | FMG |
| May 10, 2006 | K061143 | ROBERTSITE STOPCOCK Halkey-Roberts Corp. | FMG |
| Apr 13, 2006 | K060231 | CLOSED SWABABLE STOPCOCK AND MINIMAL RESIDUAL VOLUME LUER-ACTIVATED SWABABLE-STOPCOCK Elcam Medical Acal, IL | FMG |
| Sep 9, 2005 | K052330 | TRU-SWAB STOCOCK Medegen Medical Manufacturing Services | FMG |
| Sep 21, 2004 | K041779 | NIPRO DISPOSABLE STOPCOCKS, MODELS 3W-RC. NCN-3, 3W-R, 3W-L Nipro Medical Corp. | FMG |
| Sep 12, 2003 | K032393 | INDUCTION AND SAMPLING MANIFOLD (OR STOPCOCK) Elcam Medical Acal | FMG |
| Oct 18, 2002 | K022895 | ELCAM STOPCOCKS AND MANIFOLDS Medical Device Consultants, Inc. | FMG |
| Sep 11, 2001 | K012157 | CHURCHILL MEDICAL SYSTEMS STOPCOCK Churchill Medical Systems, Inc. | FMG |
| Mar 18, 2001 | K010217 | 4 PORT, 4 WAY STOPCOCK George Loo, MD | FMG |
| Jul 31, 1998 | K982368 | MANIFOLD WITH EXTENSION SET Interpore Cross Intl. | FMG |
| Jan 13, 1998 | K974083 | CONNECTA PLUS 1 AND CONNECTA PLUS 3 2-WAY AND 3-WAY STOPCOCKS Ohmeda Medical | FMG |
| Apr 2, 1997 | K964435 | PRIMARY IV SET Icu Medical, Inc. | FMG |
| Feb 21, 1997 | K961982 | TRI-FLOW THREE WAY STOPCOCK North, Inc. | FMG |
| Aug 28, 1996 | K962581 | STOPCOCK MANIFOLD GANGS Baxter Healthcare Corp | FMG |
| Apr 22, 1996 | K954970 | STOPCOCK & LUER LOCK PLUG Medex, Inc. | FMG |
| Feb 21, 1996 | K955782 | MED-NET STOPCOCKS Mednet, Inc. | FMG |
| Jan 23, 1996 | K954984 | MINIBORE STOPCOCK SET Distronic Sterile Products, Inc. | FMG |
| Oct 7, 1995 | K953573 | ICU STOPCOK WITH EXTENSION TUBING Icu Medical, Inc. | FMG |
| Apr 4, 1994 | K940070 | STOPCOCK INTRAVENOUS THERAPY Puritas Health Care, Inc. | FMG |
| Feb 22, 1994 | K932512 | MULTI-PORT MANIFOLD Baxter Healthcare Corp | FMG |
| Dec 31, 1991 | K913560 | STOPCOCK Graham Medical Products | FMG |
| Jun 3, 1991 | K911415 | TRUMPET VALVE B. Braun of America, Inc. | FMG |
| Dec 5, 1990 | K902724 | ADVANCE DISPOSABLE STOPCOCK Advance Medical Designs, Inc. | FMG |
| Sep 19, 1989 | K891234 | TERUFUSION THREE WAY STOPCOCK Terumo Medical Corp. | FMG |
| Jan 9, 1989 | K884463 | CONNECTA MONOFLO & MULTIFLO INFUSION CONNECTORS Ohmeda Medical | FMG |
| Nov 8, 1988 | K884435 | RESUBMITTED 1,3 & 4 WAY STOPCOCKS, VARIOUS PARTS Clinical Connections, Inc. | FMG |
| Oct 4, 1988 | K881805 | TU STOPCOCK Tulan Corp. C/O Richard Hamer Assoc. | FMG |
| Aug 4, 1987 | K872067 | STERICAP ASSEMBLY AND REPLACEMENT TRAY Stericap Systems | FMG |
| Aug 4, 1987 | K872066 | STERICAP STOPCOCK Stericap Systems | FMG |
| Apr 1, 1987 | K870261 | VIGGO EXACTA PRESSURE MONITORING SYSTEM Ohmeda Medical | FMG |
| Apr 1, 1987 | K864900 | VIGGO EXACTA PRESSURE MONITORING KIT Ohmeda Medical | FMG |
| Mar 13, 1987 | K870324 | #014460-120 3-WAY & #014461-120 4-WAY STOPCOCK Clinical Connections, Inc. | FMG |
| Jan 20, 1987 | K864440 | CHURCHILL 3-WAY STOPCOCK Churchill Corp. | FMG |
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