Device type

Endoscope Introducer Kit

Product code NWU · Class II · 21 CFR 876.1500 · Gastroenterology, Urology

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.

FDA classification database