FDA product code LXK: Scrapper, Skin Specimen

LXK is the FDA product code for scrapper, skin specimen. It is a Class I device, regulated under 21 CFR 878.4800 and reviewed by the General and Plastic Surgery panel. FDA has cleared 1 510(k) submission under LXK. The average 510(k) review took 20 days (median 20).

Classification

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

Top LXK applicants

Most recent LXK clearances

Recalls for LXK devices

openFDA lists no recalls for product code LXK.

Frequently asked questions

What is FDA product code LXK?

LXK is the FDA product code for scrapper, skin specimen. It is a Class I device, regulated under 21 CFR 878.4800 and reviewed by the General and Plastic Surgery panel.

What device class is LXK?

Class I, regulation 21 CFR 878.4800. Typical premarket route: 510(k) exempt.

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

Across 1 cleared submissions the average was 20 days from receipt to decision (median 20).

Which companies have the most LXK clearances?

Ortho Pharmaceutical Corp. (1).

Next steps

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