FDA product code KXG: Applicator, Absorbent Tipped, Sterile

KXG is the FDA product code for applicator, absorbent tipped, sterile. It is a Class I device, regulated under 21 CFR 880.6025 and reviewed by the General Hospital panel. FDA has cleared 1 510(k) submission under KXG. The average 510(k) review took 27 days (median 27). FDA has posted 10 recalls for KXG devices, 5 initiated in the last five years.

Classification

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

Top KXG applicants

Most recent KXG clearances

Recalls for KXG devices

10 product recalls in 9 recall events; 5 initiated in the last five years and 5 still open. Most recent: 2024-02-21.

Frequently asked questions

What is FDA product code KXG?

KXG is the FDA product code for applicator, absorbent tipped, sterile. It is a Class I device, regulated under 21 CFR 880.6025 and reviewed by the General Hospital panel.

What device class is KXG?

Class I, regulation 21 CFR 880.6025. Typical premarket route: 510(k) exempt.

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

Across 1 cleared submissions the average was 27 days from receipt to decision (median 27).

Which companies have the most KXG clearances?

Pollak (Intl.), Ltd. (1).

Have KXG devices been recalled?

Yes: 10 product recalls across 9 recall events; the most recent began 2024-02-21.

Next steps

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