FDA product code NWO: Kit, Catheter, Urinary (Exludes Hiv Testing)

NWO is the FDA product code for kit, catheter, urinary (exludes hiv testing). It is a Class II device, regulated under 21 CFR 876.5130 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 1 510(k) submission under NWO. The average 510(k) review took 76 days (median 76). FDA has posted 3 recalls for NWO devices.

Definition

Urinary Catheterization Kit (Excludes HIV Testing)

Classification

Compare with all 510(k) review times · Search every NWO clearance

Top NWO applicants

Most recent NWO clearances

Recalls for NWO devices

3 product recalls in 3 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2016-01-07.

Frequently asked questions

What is FDA product code NWO?

NWO is the FDA product code for kit, catheter, urinary (exludes hiv testing). It is a Class II device, regulated under 21 CFR 876.5130 and reviewed by the Gastroenterology and Urology panel.

What device class is NWO?

Class II, regulation 21 CFR 876.5130. Typical premarket route: 510(k).

How long does a 510(k) take for product code NWO?

Across 1 cleared submissions the average was 76 days from receipt to decision (median 76).

Which companies have the most NWO clearances?

Colorado Catheter Company, Inc. (1).

Have NWO devices been recalled?

Yes: 3 product recalls across 3 recall events; the most recent began 2016-01-07.

Next steps

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