FDA product code KBJ: Curette, Adenoid

KBJ is the FDA product code for curette, adenoid. 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 KBJ. The average 510(k) review took 24 days (median 24). FDA has posted 1 recall for KBJ devices.

Classification

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

Top KBJ applicants

Most recent KBJ clearances

Recalls for KBJ devices

1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2004-01-29.

Frequently asked questions

What is FDA product code KBJ?

KBJ is the FDA product code for curette, adenoid. 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 KBJ?

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

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

Across 1 cleared submissions the average was 24 days from receipt to decision (median 24).

Which companies have the most KBJ clearances?

Kelleher Corp. (1).

Have KBJ devices been recalled?

Yes: 1 product recalls across 1 recall events; the most recent began 2004-01-29.

Next steps

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