FDA product code KDO: Rongeur, Cystoscopic, Hot

KDO is the FDA product code for rongeur, cystoscopic, hot. It is a Class II device, regulated under 21 CFR 876.1500 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 1 510(k) submission under KDO. The average 510(k) review took 444 days (median 444).

Classification

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

Top KDO applicants

Most recent KDO clearances

Recalls for KDO devices

openFDA lists no recalls for product code KDO.

Frequently asked questions

What is FDA product code KDO?

KDO is the FDA product code for rongeur, cystoscopic, hot. It is a Class II device, regulated under 21 CFR 876.1500 and reviewed by the Gastroenterology and Urology panel.

What device class is KDO?

Class II, regulation 21 CFR 876.1500. Typical premarket route: 510(k).

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

Across 1 cleared submissions the average was 444 days from receipt to decision (median 444).

Which companies have the most KDO clearances?

Westmark Hospital Supplies (1).

Next steps

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