NWU · Class II · 21 CFR 876.1500

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.

3
Total
3
Cleared
99d
Avg days
1981
Since

FDA 510(k) Cleared Endoscope Introducer Kit Devices (Product Code NWU)

3 devices
1–3 of 3
No devices found for this product code.

About Product Code NWU - Regulatory Context