NWU

3 FDA 510(k) clearances · Product code

FDA profile

Official device name

Endoscope Introducer Kit

Device class

Class II (moderate risk)

Regulation

21 CFR 876.1500

Medical specialty

Gastroenterology, Urology

FDA definition

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.

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