FDA product code NWI: Electrosurgical Electrode Kit

NWI is the FDA product code for electrosurgical electrode kit. It is a Class II device, regulated under 21 CFR 876.4300 and reviewed by the Gastroenterology and Urology panel. Devices under NWI reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it. FDA has posted 1 recall for NWI devices.

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.

Classification

Recalls for NWI devices

1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2004-09-24.

Frequently asked questions

What is FDA product code NWI?

NWI is the FDA product code for electrosurgical electrode kit. It is a Class II device, regulated under 21 CFR 876.4300 and reviewed by the Gastroenterology and Urology panel.

What device class is NWI?

Class II, regulation 21 CFR 876.4300. Typical premarket route: 510(k) exempt.

Have NWI devices been recalled?

Yes: 1 product recalls across 1 recall events; the most recent began 2004-09-24.

Next steps

• Run an FDA pathway report with predicate devices for product code NWI
• Run a recall and safety report across every NWI manufacturer
• Watch product code NWI for new clearances and recalls

Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.

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