NWI

Electrosurgical Electrode Kit

Product code

NWI

Device name

Electrosurgical Electrode Kit

Device class

Class 2

21 CFR

21 CFR 876.4300

Medical specialty

Gastroenterology, Urology

Marketing pathway

Enforcement Discretion

FDA classification 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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).