FDA Product Code NWU: Endoscope Introducer 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 Kit, As Described In The Guidance Above, Is Under Enforcement Discretion, And Does Not Require A Premarket Notification (510(k)) To Market.

Leading manufacturers include American Pharmaseal Div. Ahsc and Candela Laser Corp..