Disposable Stopcocks
FDA 510(k) K842173 · Procedure Products, Inc.
510(k) numberK842173
Submission
- Device name
- Disposable Stopcocks
- Applicant
- Procedure Products, Inc.
Mchenry, IL, US - Received
- May 15, 1984
- Decision date
- September 5, 1984
- 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 |
|---|---|---|
| K161812 | Freedom SyringeFMF · Abbreviated | 03/27/2017SE |
| K923194 | Insufflator Connecting FilterHIF · Traditional | 10/08/1993SE |
| K922536 | Torque DeviceDQX · Traditional | 12/10/1992SE |
| K914128 | Connecting SetDQO · Traditional | 11/27/1991SE |
| K910673 | Bag SpigotKPE · Traditional | 04/24/1991SE |
| K884985 | Modified 10CC Syringe Control Ring SetFMF · Traditional | 12/20/1988SE |
| K874747 | 10CC Syringe Control Ring SetFMF · Traditional | 02/04/1988SE |
| K874037 | Angio Waste Fluids Dump BagDQO · Traditional | 01/29/1988SE |
| K853749 | Custom Coronary Manifold KitsDTL · Traditional | 01/13/1986SE |
| K833554 | Material Addition Lexan & K-ResinDQO · Traditional | 03/12/1984SE |
Questions and answers
When was Disposable Stopcocks cleared by the FDA?
Disposable Stopcocks (K842173) received a 510(k) decision of Substantially Equivalent on September 5, 1984, 113 days after the submission was received.
What is the product code of K842173?
The FDA product code is FMG – Stopcock, I.V. Set, a Class II (moderate risk) device regulated under 21 CFR 880.5440.