FMG — Stopcock, I.V. Set Class II
FDA Device Classification
Classification Details
- Product Code
- FMG
- Device Class
- Class II
- Regulation Number
- 880.5440
- Submission Type
- Review Panel
- HO
- Medical Specialty
- General Hospital
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
| K242255 | medex | Qitexio® 4-Way Stopcock (QIT014) | April 29, 2025 |
| K223499 | m/s romsons international | Three Way Stop Cock | July 21, 2023 |
| K223175 | baxter healthcare corporation | lntravascular Administration Sets with Stopcock and Manifold | March 10, 2023 |
| K211204 | elcam medical acal | SafePort(TM) Manifold (or Stopcock) | September 15, 2022 |
| K210516 | yomura technologies | Clicky Cross | May 16, 2022 |
| K190539 | monumedical | TurnSignal Stopcocks Sterile, TurnSignal Stopcocks Buld Non Sterile, TurnSignal | October 22, 2019 |
| K190489 | elcam medical acal | Elcam Stopcocks and Manifolds | April 23, 2019 |
| K172266 | dynarex corporation | Dynarex Three-Way Stopcock | March 14, 2018 |
| K141254 | elcam medical acal | ELCAM STOPCOCKS AND MANIFOLDS | July 30, 2014 |
| K123084 | elcam medical acal | DISPOSABLE HIGH PRESSURE STOPCOCK/MANIFOLD MODEL HP STOPCOCK, MP STOPCOCK, HP MA | May 23, 2013 |
| K130245 | baxter healthcare | LARGE BORE STOPCOCK WITH ROTATING MALE LUER LOCK/LARGE BORE STOPCOCK WITH EXTENS | March 1, 2013 |
| K082110 | surgin surgical instrumentation | DUAL SYRINGE HOLDER | June 17, 2009 |
| K082836 | icu medical | ICU MEDICAL UNIVERSAL SINGLE-USE SPIKES | February 25, 2009 |
| K082106 | elcam medical acal | ELCAM ANTIMICROBIAL CLOSED STOPCOCKS (DSS AND TSS) | October 2, 2008 |
| K080077 | icu medical | CLAVE STOPCOCK | February 13, 2008 |
| K071400 | cardinal health, alaris products | SMARTSITE STOPCOCK | December 14, 2007 |
| K070143 | jms north america | JMS PLANECTA STOPCOCK | April 10, 2007 |
| K053405 | elcam medical acal | BACSTOP | May 11, 2006 |
| K061143 | halkey-roberts | ROBERTSITE STOPCOCK | May 10, 2006 |
| K060231 | elcam medical acal | CLOSED SWABABLE STOPCOCK AND MINIMAL RESIDUAL VOLUME LUER-ACTIVATED SWABABLE-STO | April 13, 2006 |