3&4 Way Plastic Stopcocks, Nonsterile
FDA 510(k) K792125 · Tronomed, Inc.
510(k) numberK792125
Submission
- Device name
- 3&4 Way Plastic Stopcocks, Nonsterile
- Applicant
- Tronomed, Inc.
Mchenry, IL, US - Received
- October 24, 1979
- Decision date
- January 16, 1980
- 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
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|---|---|---|---|
| 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 |
|---|---|---|
| K952659 | Tronomate Patient Cable & Leadwire SystemDSA · Traditional | 01/11/1996SE |
| K853303 | Lifelinc LeadwireBZQ · Traditional | 09/18/1985SE |
| K853452 | Life Linc Patient CableBZQ · Traditional | 09/10/1985SE |
| K841092 | High Pressure Flex. Connecting TubingDXT · Traditional | 07/24/1985SE |
| K792128 | Sterile Extension Tubes Indiv. Pkg.FMG · Traditional | 01/16/1980SE |
| K792127 | Plas. Stck. W/Extension Tube/SterileFMG · Traditional | 01/16/1980SE |
| K792126 | 3&4 Way Plastic Sterile Stpcks. Pkg.FMG · Traditional | 01/16/1980SE |
| K792124 | Tandem Assembled 3&4 Way StopcocksFMG · Traditional | 01/16/1980SE |
| K771645 | Electrocardiographic Cablhs & Lead WireDSA · Traditional | 10/18/1977SE |
| K771027 | Electrocardiographic Patient CablesDSA · Traditional | 07/05/1977SE |
Questions and answers
When was 3&4 Way Plastic Stopcocks, Nonsterile cleared by the FDA?
3&4 Way Plastic Stopcocks, Nonsterile (K792125) received a 510(k) decision of Substantially Equivalent on January 16, 1980, 84 days after the submission was received.
What is the product code of K792125?
The FDA product code is FMG – Stopcock, I.V. Set, a Class II (moderate risk) device regulated under 21 CFR 880.5440.