Epidural Block Procedure Pack
FDA 510(k) K770096 · American Viggo
510(k) numberK770096
Submission
- Device name
- Epidural Block Procedure Pack
- Applicant
- American Viggo
Mchenry, IL, US - Received
- January 17, 1977
- Decision date
- February 25, 1977
- 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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| K161075 | Arrow Epidural Catheter KitCAZ · Traditional | Teleflexmedical, Inc. | 10/04/2016SE |
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More from Smiths Medical Asd, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K771339 | Male Luer Lock PlugFPA · Traditional | 08/02/1977SE |
| K770528 | Needle, MembraneFMI · Traditional | 04/29/1977SE |
| K770181 | I.V. Catheter Placement UnitFOZ · Traditional | 03/30/1977SE |
| K770174 | Luer-Lock Extension SetFPK · Traditional | 03/30/1977SE |
| K770154 | 3-WAY Stopcock with Luer-Lock FittingKGZ · Traditional | 02/28/1977SE |
| K760679 | 4-WAY Stopcock W/7CM Tubing,FMG · Traditional | 12/02/1976SE |
| K760678 | 4-WAY Stopcock W/100 CM Tubing, Luer-LkFMG · Traditional | 12/02/1976SE |
| K760667 | 4-WAY Stopcock W/10 CM Exten. TubingFMG · Traditional | 12/02/1976SE |
| K760666 | 4-WAY Stopcock W/Luer-Lock FittingFMG · Traditional | 12/02/1976SE |
Questions and answers
When was Epidural Block Procedure Pack cleared by the FDA?
Epidural Block Procedure Pack (K770096) received a 510(k) decision of Substantially Equivalent on February 25, 1977, 39 days after the submission was received.
What is the product code of K770096?
The FDA product code is CAZ – Anesthesia Conduction Kit, a Class II (moderate risk) device regulated under 21 CFR 868.5140.