FDA product code IWN: Cassette, Measurement, Ardran-Crooks

IWN is the FDA product code for cassette, measurement, ardran-crooks. It is a Class I device, regulated under 21 CFR 892.1940 and reviewed by the Radiology panel. FDA has cleared 1 510(k) submission under IWN. The average 510(k) review took 67 days (median 67).

Classification

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

Top IWN applicants

Most recent IWN clearances

Recalls for IWN devices

openFDA lists no recalls for product code IWN.

Frequently asked questions

What is FDA product code IWN?

IWN is the FDA product code for cassette, measurement, ardran-crooks. It is a Class I device, regulated under 21 CFR 892.1940 and reviewed by the Radiology panel.

What device class is IWN?

Class I, regulation 21 CFR 892.1940. Typical premarket route: 510(k) exempt.

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

Across 1 cleared submissions the average was 67 days from receipt to decision (median 67).

Which companies have the most IWN clearances?

Radiation Measurements, Inc. (1).

Next steps

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