Anago Spinal Anesthesia Tray
FDA 510(k) K930161 · Anago, Inc.
510(k) numberK930161
Submission
- Device name
- Anago Spinal Anesthesia Tray
- Applicant
- Anago, Inc.
Fort Worth, TX, US - Received
- January 13, 1993
- Decision date
- July 6, 1993
- Decision
- Unknown (SEKD)
- 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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| 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 |
|---|---|---|
| K925659 | U.C.E.Z. Lens Cleaner KitOCT · Traditional | 09/17/1993SE |
| K926590 | Anago Disposable Instant Cold PackIMD · Traditional | 05/26/1993SE |
| K926589 | Anago Warm PackIMD · Traditional | 05/26/1993SE |
| K926137 | Anago Fem-Cool/Fem-Cool PetiteIMD · Traditional | 05/26/1993SE |
| K920615 | Anago Continuous Epidural Anesthesia Tray/KitCAZ · Traditional | 03/20/1993SEKD |
| K915415 | Guardall ShieldLYU · Traditional | 10/15/1992SE |
| K913558 | Reliable Cone Style Face MaskFXX · Traditional | 11/07/1991SE |
| K905865 | Anti-For Surgical Face MaskFXX · Traditional | 03/06/1991SE |
| K905749 | Surgical Face MaskFXX · Traditional | 03/04/1991SE |
| K904276 | Disposable Beard CoverFXY · Traditional | 11/21/1990SE |
Questions and answers
When was Anago Spinal Anesthesia Tray cleared by the FDA?
Anago Spinal Anesthesia Tray (K930161) received a 510(k) decision of Unknown on July 6, 1993, 174 days after the submission was received.
What is the product code of K930161?
The FDA product code is CAZ – Anesthesia Conduction Kit, a Class II (moderate risk) device regulated under 21 CFR 868.5140.