Morell Injector
FDA 510(k) K951870 · Incutech, Inc.
510(k) numberK951870
Submission
- Device name
- Morell Injector
- Applicant
- Incutech, Inc.
Greensboro, NC, US - Received
- April 21, 1995
- Decision date
- January 22, 1996
- Decision
- Unknown (SESK)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- CAZ – Anesthesia Conduction Kit
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5140
- Specialty
- Anesthesiology
This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.
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|---|---|---|---|
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| K202699 | E-Cath STIM acc. TsuiCAZ · Special | PAJUNK GmbH Medizintechnologie | 12/29/2020SE |
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| K161075 | Arrow Epidural Catheter KitCAZ · Traditional | Teleflexmedical, Inc. | 10/04/2016SE |
| K153652 | ARROW FlexBlock Continuous Peripheral Nerve Block Catheter Kit/SetCAZ · Traditional | Teleflex, Inc. | 06/21/2016SE |
| K143581 | Arrow Epidural Catheter KitCAZ · Traditional | Teleflexmedical, Inc. | 06/26/2015SE |
| K122690 | Ultraquik Peripheral Nerve Block NeedleCAZ · Traditional | Arrow International, Inc. | 12/21/2012SE |
| K110053 | Correctinject Safety System, Catheter Connector, Filter, Infusion Adaptor, Syringe KitCAZ · Traditional | Smiths Medical Asd, Inc. | 09/14/2012SE |
More from Smiths Medical Asd, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K960619 | More-L Injector Kit PlusCAZ · Traditional | 06/20/1996SE |
| K942394 | Safe Vent SystemFMF · Traditional | 01/27/1995SE |
| K941731 | Empty, Solution Transfer Container with Detatchable Leg SetKPE · Traditional | 07/22/1994SE |
| K940258 | Solution Transfer Container W/Attached Leg Set (Empty)KPE · Traditional | 03/28/1994SE |
Questions and answers
When was Morell Injector cleared by the FDA?
Morell Injector (K951870) received a 510(k) decision of Unknown on January 22, 1996, 276 days after the submission was received.
What is the product code of K951870?
The FDA product code is CAZ – Anesthesia Conduction Kit, a Class II (moderate risk) device regulated under 21 CFR 868.5140.