Micor Anesthesia Conduction Kit
FDA 510(k) K001940 · Micor, Inc.
510(k) numberK001940
Submission
- Device name
- Micor Anesthesia Conduction Kit
- Applicant
- Micor, Inc.
Allison Park, PA, US - Received
- June 26, 2000
- Decision date
- August 11, 2000
- 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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More from Smiths Medical Asd, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K031600 | Conduction CatheterFRN · Traditional | 08/13/2003SE |
| K003966 | Wundcath Conduction CatheterFRN · Traditional | 07/17/2001SE |
| K001717 | Micor Conduction CatheterBSO · Traditional | 09/20/2000SE |
| K991879 | Spring-Wound Epidural CatheterBSO · Traditional | 10/28/1999SE |
| K861008 | Percutaneous CathetersDQY · Traditional | 04/29/1986SE |
| K860339 | Percutaneous CathetersDQY · Traditional | 03/31/1986SE |
| K854018 | Angiography CathetersDQO · Traditional | 01/16/1986SE |
Questions and answers
When was Micor Anesthesia Conduction Kit cleared by the FDA?
Micor Anesthesia Conduction Kit (K001940) received a 510(k) decision of Substantially Equivalent on August 11, 2000, 46 days after the submission was received.
What is the product code of K001940?
The FDA product code is CAZ – Anesthesia Conduction Kit, a Class II (moderate risk) device regulated under 21 CFR 868.5140.