Product code FMG
- Device name
- Stopcock, I.V. Set
- Medical specialty
- General Hospital
- Device class
- 2
- Regulation number
- 880.5440
- Review panel
- HO
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K242255 | Qitexio® 4-Way Stopcock (QIT014) | Medex | 2025-04-29 |
| K223499 | Three Way Stop Cock | M/S Romsons International | 2023-07-21 |
| K223175 | lntravascular Administration Sets with Stopcock and Manifold | Baxter Healthcare Corporation | 2023-03-10 |
| K211204 | SafePort(TM) Manifold (or Stopcock) | Elcam Medical Acal | 2022-09-15 |
| K210516 | Clicky Cross | Yomura Technologies, Inc. | 2022-05-16 |
| K190539 | TurnSignal Stopcocks Sterile, TurnSignal Stopcocks Buld Non Sterile, TurnSignal Stopcocks with Manifolds Sterile, TurnSignal Stopcocks with Manifolds Bulk Non Sterile | Monumedical, LLC | 2019-10-22 |
| K190489 | Elcam Stopcocks and Manifolds | Elcam Medical Acal | 2019-04-23 |
| K172266 | Dynarex Three-Way Stopcock | Dynarex Corporation | 2018-03-14 |
| K141254 | ELCAM STOPCOCKS AND MANIFOLDS | Elcam Medical Acal | 2014-07-30 |
| K123084 | DISPOSABLE HIGH PRESSURE STOPCOCK/MANIFOLD MODEL HP STOPCOCK, MP STOPCOCK, HP MANIFOLD, PHP MANIFOLD | Elcam Medical Acal | 2013-05-23 |
| K130245 | LARGE BORE STOPCOCK WITH ROTATING MALE LUER LOCK/LARGE BORE STOPCOCK WITH EXTENSION SET, GANG LARGE BORE STOPCOCK MANIFO | Baxter Healthcare Corp | 2013-03-01 |
| K082110 | DUAL SYRINGE HOLDER | Surgin Surgical Instrumentation, Inc. | 2009-06-17 |
| K082836 | ICU MEDICAL UNIVERSAL SINGLE-USE SPIKES | Icu Medical, Inc. | 2009-02-25 |
| K082106 | ELCAM ANTIMICROBIAL CLOSED STOPCOCKS (DSS AND TSS) | Elcam Medical Acal | 2008-10-02 |
| K080077 | CLAVE STOPCOCK | Icu Medical, Inc. | 2008-02-13 |
| K071400 | SMARTSITE STOPCOCK | Cardinal Health, Alaris Products | 2007-12-14 |
| K070143 | JMS PLANECTA STOPCOCK | Jms North America Corp. | 2007-04-10 |
| K053405 | BACSTOP | Elcam Medical Acal | 2006-05-11 |
| K061143 | ROBERTSITE STOPCOCK | Halkey-Roberts Corp. | 2006-05-10 |
| K060231 | CLOSED SWABABLE STOPCOCK AND MINIMAL RESIDUAL VOLUME LUER-ACTIVATED SWABABLE-STOPCOCK | Elcam Medical Acal | 2006-04-13 |
| K052330 | TRU-SWAB STOCOCK | Medegen Medical Manufacturing Services | 2005-09-09 |
| K041779 | NIPRO DISPOSABLE STOPCOCKS, MODELS 3W-RC. NCN-3, 3W-R, 3W-L | Nipro Medical Corp. | 2004-09-21 |
| K032393 | INDUCTION AND SAMPLING MANIFOLD (OR STOPCOCK) | Elcam Medical Acal | 2003-09-12 |
| K022895 | ELCAM STOPCOCKS AND MANIFOLDS | Medical Device Consultants, Inc. | 2002-10-18 |
| K012157 | CHURCHILL MEDICAL SYSTEMS STOPCOCK | Churchill Medical Systems, Inc. | 2001-09-11 |
| K010217 | 4 PORT, 4 WAY STOPCOCK | George Loo, MD | 2001-03-18 |
| K982368 | MANIFOLD WITH EXTENSION SET | Interpore Cross Intl. | 1998-07-31 |
| K974083 | CONNECTA PLUS 1 AND CONNECTA PLUS 3 2-WAY AND 3-WAY STOPCOCKS | Ohmeda Medical | 1998-01-13 |
| K964435 | PRIMARY IV SET | Icu Medical, Inc. | 1997-04-02 |
| K961982 | TRI-FLOW THREE WAY STOPCOCK | North, Inc. | 1997-02-21 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 10193489896824 | Medline Industries, Inc. | MEDLINE INDUSTRIES, INC. | 2022-08-04 |
| 10193489191684 | MEDLINE | MEDLINE INDUSTRIES, INC. | 2020-04-15 |
| 10193489191707 | MEDLINE | MEDLINE INDUSTRIES, INC. | 2020-04-15 |
| 00887709008045 | ICU Medical | ICU MEDICAL, INC. | 2017-04-17 |
| 10351688506368 | Medex | ICU MEDICAL, INC. | 2017-01-19 |
| 10351688501332 | Medex | ICU MEDICAL, INC. | 2016-12-30 |
| 10351688505255 | Medex | ICU MEDICAL, INC. | 2016-12-29 |
| 10351688506788 | Medex | ICU MEDICAL, INC. | 2016-12-29 |
| 10351688506771 | Medex | ICU MEDICAL, INC. | 2016-12-29 |
| 10351688506764 | Medex | ICU MEDICAL, INC. | 2016-12-29 |
| 10351688506719 | Medex | ICU MEDICAL, INC. | 2016-12-29 |
| 10351688506610 | Medex | ICU MEDICAL, INC. | 2016-12-29 |
| 10351688505774 | Medex | ICU MEDICAL, INC. | 2016-12-29 |
| 10351688505569 | Medex | ICU MEDICAL, INC. | 2016-12-29 |
| 10351688505545 | Medex | ICU MEDICAL, INC. | 2016-12-29 |
| 10351688504180 | Medex | ICU MEDICAL, INC. | 2016-12-29 |
| 10351688504173 | Medex | ICU MEDICAL, INC. | 2016-12-29 |
| 10351688504166 | Medex | ICU MEDICAL, INC. | 2016-12-29 |
| 10351688504159 | Medex | ICU MEDICAL, INC. | 2016-12-29 |
| 10351688504142 | Medex | ICU MEDICAL, INC. | 2016-12-29 |
| 10351688506184 | Medex | ICU MEDICAL, INC. | 2016-12-28 |
| 10351688506214 | Medex | ICU MEDICAL, INC. | 2016-12-28 |
| 10351688506337 | Medex | ICU MEDICAL, INC. | 2016-12-28 |
| 10351688505330 | Medex | ICU MEDICAL, INC. | 2016-10-13 |
| 10351688505361 | Medex | ICU MEDICAL, INC. | 2016-10-13 |
| 08498840009581 | VYGON | Vygon Corporation | 2016-09-07 |
| 08498840000878 | VYGON | Vygon Corporation | 2016-09-06 |
| 08498840001011 | VYGON | Vygon Corporation | 2016-08-04 |
| 08498840000694 | VYGON | Vygon Corporation | 2016-08-03 |
| 08498840000779 | VYGON | Vygon Corporation | 2016-08-01 |