Ultraquik Peripheral Nerve Block Needle
FDA 510(k) K122690 · Arrow International, Inc.
510(k) numberK122690
Submission
- Device name
- Ultraquik Peripheral Nerve Block Needle
- Applicant
- Arrow International, Inc.
Reading, PA, US - Received
- September 4, 2012
- Decision date
- December 21, 2012
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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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| 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 |
| K110053 | Correctinject Safety System, Catheter Connector, Filter, Infusion Adaptor, Syringe KitCAZ · Traditional | Smiths Medical Asd, Inc. | 09/14/2012SE |
| K122027 | Arrow Flexblock Continuous Peripheral Nerve Block CatheterCAZ · Traditional | Arrow International, Inc. | 08/28/2012SE |
More from Arrow International, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K250542 | AC3 Range Intra-Aortic Balloon PumpDSP · Special | 03/26/2025SE |
| K232343 | AC3 Series IABPDSP · Special | 08/30/2023SE |
| K222341 | Arrow 0.2 Micron Flat Filter, GVSCAZ · Traditional | 02/13/2023SE |
| K201112 | AC3 IABP, AC3 Optimus IABP, AutoCAT2 Wave IABP, AutoCAT2 IABPDSP · Special | 05/27/2020SE |
| K200634 | Arrow FiberOptix Intra-Aortic Balloon Catheter KitDSP · Special | 04/09/2020SE |
| K190101 | UltraFlex IABDSP · Traditional | 06/28/2019SE |
| K190117 | Fiberoptix IABDSP · Traditional | 06/13/2019SE |
| K162820 | AC3 Series IABP SystemDSP · Traditional | 03/31/2017SE |
| K141051 | Vectorflow; Antegrade Chronic Hemodialysis Catheter, Retrograde Chronic Hemodialysis…MSD · Special | 07/07/2014SE |
| K130192 | Nextstep RetrogradeMSD · Traditional | 05/10/2013SESK |
Questions and answers
When was Ultraquik Peripheral Nerve Block Needle cleared by the FDA?
Ultraquik Peripheral Nerve Block Needle (K122690) received a 510(k) decision of Substantially Equivalent on December 21, 2012, 108 days after the submission was received.
What is the product code of K122690?
The FDA product code is CAZ – Anesthesia Conduction Kit, a Class II (moderate risk) device regulated under 21 CFR 868.5140.