FMG — Stopcock, I.V. Set Class II
FDA product code FMG covers "Stopcock, I.V. Set", a Class II medical device regulated under 21 CFR 880.5440. Submissions are reviewed by the General Hospital panel. At least 20 recent 510(k) clearances have been granted under this product code.
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 |