FDA Product Code CAZ: Anesthesia Conduction Kit
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.
Leading manufacturers include Arrow Intl., Inc., Kendall Healthcare Products Co. Div.Of Tyco Health and PAJUNK GmbH Medizintechnologie.
FDA 510(k) Cleared Anesthesia Conduction Kit Devices (Product Code CAZ)
About Product Code CAZ - Regulatory Context
510(k) Submission Activity
156 total 510(k) submissions under product code CAZ since 1976, with 156 receiving FDA clearance (average review time: 129 days).
Submission volume has remained relatively stable over the observed period, with 1 submissions in the last 24 months.
FDA 510(k) Review Time - CAZ Product Code
Recent submissions under CAZ have taken an average of 151 days to reach a decision - up from 129 days historically. Manufacturers should account for longer review timelines in current project planning.
CAZ devices are reviewed by the Anesthesiology panel. Browse all Anesthesiology devices →