FDA product code GXE: Leukotome

GXE is the FDA product code for leukotome. It is a Class I device, regulated under 21 CFR 882.4600 and reviewed by the Neurology panel. FDA has cleared 1 510(k) submission under GXE. The average 510(k) review took 354 days (median 354). FDA has posted 1 recall for GXE devices.

Classification

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

Top GXE applicants

Most recent GXE clearances

Recalls for GXE devices

1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2006-01-17.

Frequently asked questions

What is FDA product code GXE?

GXE is the FDA product code for leukotome. It is a Class I device, regulated under 21 CFR 882.4600 and reviewed by the Neurology panel.

What device class is GXE?

Class I, regulation 21 CFR 882.4600. Typical premarket route: 510(k) exempt.

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

Across 1 cleared submissions the average was 354 days from receipt to decision (median 354).

Which companies have the most GXE clearances?

Dantec Medical, Inc. (1).

Have GXE devices been recalled?

Yes: 1 product recalls across 1 recall events; the most recent began 2006-01-17.

Next steps

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