FDA product code KBW: Screw, Oral

KBW is the FDA product code for screw, oral. It is a Class I device, regulated under 21 CFR 874.4420 and reviewed by the Ear, Nose and Throat panel. FDA has cleared 1 510(k) submission under KBW. The average 510(k) review took 94 days (median 94). FDA has posted 1 recall for KBW devices.

Classification

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

Top KBW applicants

Most recent KBW clearances

Recalls for KBW devices

1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2010-06-25.

Frequently asked questions

What is FDA product code KBW?

KBW is the FDA product code for screw, oral. It is a Class I device, regulated under 21 CFR 874.4420 and reviewed by the Ear, Nose and Throat panel.

What device class is KBW?

Class I, regulation 21 CFR 874.4420. Typical premarket route: 510(k) exempt.

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

Across 1 cleared submissions the average was 94 days from receipt to decision (median 94).

Which companies have the most KBW clearances?

Gam Industries, Inc. (1).

Have KBW devices been recalled?

Yes: 1 product recalls across 1 recall events; the most recent began 2010-06-25.

Next steps

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