3-WAY Stopcock
FDA 510(k) K782168 · Medex, Inc.
510(k) numberK782168
Submission
- Device name
- 3-WAY Stopcock
- Applicant
- Medex, Inc.
Walker, MI, US - Received
- December 29, 1978
- Decision date
- February 22, 1979
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FMG – Stopcock, I.V. Set
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5440
- Specialty
- General Hospital
Other 510(k)s with product code FMG
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K242255 | Qitexio® 4-Way Stopcock (QIT014)FMG · Traditional | Medex | 04/29/2025SE |
| K223499 | Three Way Stop CockFMG · Traditional | M/S Romsons International | 07/21/2023SE |
| K223175 | lntravascular Administration Sets with Stopcock and ManifoldFMG · Traditional | Baxter Healthcare Corporation | 03/10/2023SE |
| K211204 | SafePort(TM) Manifold (or Stopcock)FMG · Traditional | Elcam Medical Acal | 09/15/2022SE |
| K210516 | Clicky CrossFMG · Traditional | Yomura Technologies, Inc. | 05/16/2022SE |
| K190539 | TurnSignal Stopcocks Sterile, TurnSignal Stopcocks Buld Non Sterile, TurnSignal…FMG · Traditional | Monumedical, LLC | 10/22/2019SE |
| K190489 | Elcam Stopcocks and ManifoldsFMG · Special | Elcam Medical Acal | 04/23/2019SE |
| K172266 | Dynarex Three-Way StopcockFMG · Traditional | Dynarex Corporation | 03/14/2018SE |
| K141254 | Elcam Stopcocks and ManifoldsFMG · Special | Elcam Medical Acal | 07/30/2014SE |
| K123084 | Disposable High Pressure Stopcock/Manifold Model HP Stopcock, MP Stopcock, HP Manifold…FMG · Traditional | Elcam Medical Acal | 05/23/2013SE |
More from Elcam Medical Acal
| 510(k) | Device | Decision |
|---|---|---|
| K242255 | Qitexio® 4-Way Stopcock (QIT014)FMG · Traditional | 04/29/2025SE |
| K203738 | QitexioFMF · Traditional | 03/14/2022SE |
| K042432 | Pharmguard Toolbox, Model G6000782FRN · Traditional | 01/04/2005SE |
| K040899 | Medex 3000 Series MR Syringe Infusion PumpFRN · Traditional | 04/30/2004SE |
| K020780 | Transtar Intracranial Pressure Transducer, Model MX950ICPGWM · Abbreviated | 05/20/2002SE |
| K000328 | Medex 3000 Series MRI Compatible Syringe Infusion PumpFRN · Traditional | 05/09/2000SE |
| K982640 | Medex 3000 Series Syringe Infusion PumpFRN · Traditional | 04/06/1999ST |
| K982123 | Contrast Control DeviceFPA · Traditional | 07/21/1998SE |
| K955231 | Medfusion Model 2001 Syringe Infusion PumpFRN · Traditional | 07/18/1996ST |
| K961404 | MX960 Reusable Pressure TransducerDRS · Traditional | 06/27/1996SE |
Questions and answers
When was 3-WAY Stopcock cleared by the FDA?
3-WAY Stopcock (K782168) received a 510(k) decision of Substantially Equivalent on February 22, 1979, 55 days after the submission was received.
What is the product code of K782168?
The FDA product code is FMG – Stopcock, I.V. Set, a Class II (moderate risk) device regulated under 21 CFR 880.5440.