More-L Injector Kit Plus
FDA 510(k) K960619 · Incutech, Inc.
510(k) numberK960619
Submission
- Device name
- More-L Injector Kit Plus
- Applicant
- Incutech, Inc.
Greensboro, NC, US - Received
- February 13, 1996
- Decision date
- June 20, 1996
- Decision
- Substantially Equivalent (SESE)
- 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.
Other 510(k)s with product code CAZ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K222341 | Arrow 0.2 Micron Flat Filter, GVSCAZ · Traditional | Arrow International, LLC | 02/13/2023SE |
| K210983 | BD Epilor SyringeCAZ · Traditional | Becton, Dickinson and Company | 05/19/2022SE |
| K201356 | Plastic LOR SyringeCAZ · Traditional | Jiangsu Caina Medical Co.,Ltd | 02/12/2021SE |
| K202699 | E-Cath STIM acc. TsuiCAZ · Special | PAJUNK GmbH Medizintechnologie | 12/29/2020SE |
| K190345 | VPCCAZ · Traditional | PAJUNK GmbH Medizintechnologie | 05/16/2019SE |
| 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 |
|---|---|---|
| K951870 | Morell InjectorCAZ · Traditional | 01/22/1996SESK |
| 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 More-L Injector Kit Plus cleared by the FDA?
More-L Injector Kit Plus (K960619) received a 510(k) decision of Substantially Equivalent on June 20, 1996, 128 days after the submission was received.
What is the product code of K960619?
The FDA product code is CAZ – Anesthesia Conduction Kit, a Class II (moderate risk) device regulated under 21 CFR 868.5140.