4-WAY Stopcock W/Luer-Lock Fitting
FDA 510(k) K760666 · American Viggo
510(k) numberK760666
Submission
- Device name
- 4-WAY Stopcock W/Luer-Lock Fitting
- Applicant
- American Viggo
Mchenry, IL, US - Received
- September 17, 1976
- Decision date
- December 2, 1976
- 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 |
|---|---|---|
| K771339 | Male Luer Lock PlugFPA · Traditional | 08/02/1977SE |
| K770528 | Needle, MembraneFMI · Traditional | 04/29/1977SE |
| K770181 | I.V. Catheter Placement UnitFOZ · Traditional | 03/30/1977SE |
| K770174 | Luer-Lock Extension SetFPK · Traditional | 03/30/1977SE |
| K770154 | 3-WAY Stopcock with Luer-Lock FittingKGZ · Traditional | 02/28/1977SE |
| K770096 | Epidural Block Procedure PackCAZ · Traditional | 02/25/1977SE |
| K760679 | 4-WAY Stopcock W/7CM Tubing,FMG · Traditional | 12/02/1976SE |
| K760678 | 4-WAY Stopcock W/100 CM Tubing, Luer-LkFMG · Traditional | 12/02/1976SE |
| K760667 | 4-WAY Stopcock W/10 CM Exten. TubingFMG · Traditional | 12/02/1976SE |
Questions and answers
When was 4-WAY Stopcock W/Luer-Lock Fitting cleared by the FDA?
4-WAY Stopcock W/Luer-Lock Fitting (K760666) received a 510(k) decision of Substantially Equivalent on December 2, 1976, 76 days after the submission was received.
What is the product code of K760666?
The FDA product code is FMG – Stopcock, I.V. Set, a Class II (moderate risk) device regulated under 21 CFR 880.5440.