Churchill Medical Systems Stopcock
FDA 510(k) K012157 · Churchill Medical Systems, Inc.
510(k) numberK012157
Submission
- Device name
- Churchill Medical Systems Stopcock
- Applicant
- Churchill Medical Systems, Inc.
Dover, NH, US - Received
- July 11, 2001
- Decision date
- September 11, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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 |
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| 510(k) | Device | Decision |
|---|---|---|
| K041038 | Churchill Medical Dual Chamber Empty ContainerKPE · Abbreviated | 12/21/2004SE |
| K021395 | Modification to 30 Extension SetFPA · Special | 05/13/2002SE |
| K013949 | Universal Vial Access Spike with Needleless ConnectorFPA · Traditional | 03/27/2002SE |
| K020544 | Wing Safe Infusion Set 20 Ga, SHS2000 Series; Wing Safe Infusion Set 19 Ga, SHS1900…FPA · Special | 03/12/2002SE |
| K013950 | Vented Vial Access DeviceFPA · Traditional | 01/10/2002SE |
| K011888 | Pressure Activated Check ValveFPA · Traditional | 09/10/2001SE |
| K011336 | Primary Solution Set with Universal Spike, Injection Site and Male Luer LockFPA · Traditional | 06/12/2001SE |
| K896333 | CMS IV FiltersFPB · Traditional | 01/11/1990SE |
| K894954 | .22 & 1.2 Micron IV FiltersFPB · Traditional | 11/13/1989SE |
| K884370 | CMS IV Extension SetsFPK · Traditional | 11/07/1988SE |
Questions and answers
When was Churchill Medical Systems Stopcock cleared by the FDA?
Churchill Medical Systems Stopcock (K012157) received a 510(k) decision of Substantially Equivalent on September 11, 2001, 62 days after the submission was received.
What is the product code of K012157?
The FDA product code is FMG – Stopcock, I.V. Set, a Class II (moderate risk) device regulated under 21 CFR 880.5440.