Tray, Curity Continuous Epidural
FDA 510(k) K760343 · Kendall Research Center
510(k) numberK760343
Submission
- Device name
- Tray, Curity Continuous Epidural
- Applicant
- Kendall Research Center
Mchenry, IL, US - Received
- July 30, 1976
- Decision date
- August 11, 1976
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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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| 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 |
|---|---|---|
| K802225 | Tender-Sorb Drain SpongesNAB · Traditional | 09/26/1980SE |
| K781357 | T.E.D. Sequential Compression SleevesJOW · Traditional | 09/20/1978SE |
| K780408 | Micronet Light Dressing SpongeNAB · Traditional | 03/22/1978SE |
| K780062 | Catheter/Hemostatic/GeriatricEZL · Traditional | 02/14/1978SE |
| K780120 | Anesthesia Tray, CaudalCAZ · Traditional | 02/06/1978SE |
| K772134 | Syringe, Irrigation, Pre-FilledKOA · Traditional | 11/28/1977SE |
| K772133 | Urine Specimen Collecting DeviceFCN · Traditional | 11/28/1977SE |
| K771655 | Curity PeakometerFFG · Traditional | 10/14/1977SE |
| K771079 | Curity Irrigation TrayGBX · Traditional | 09/15/1977SE |
| K771563 | Conform Elastic NettingFQM · Traditional | 09/12/1977SE |
Questions and answers
When was Tray, Curity Continuous Epidural cleared by the FDA?
Tray, Curity Continuous Epidural (K760343) received a 510(k) decision of Substantially Equivalent on August 11, 1976, 12 days after the submission was received.
What is the product code of K760343?
The FDA product code is CAZ – Anesthesia Conduction Kit, a Class II (moderate risk) device regulated under 21 CFR 868.5140.