510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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GXEClass I

Leukotome

21 CFR 882.4600 / Neurology
FDA source (opens on fda.gov)

GXE is the FDA product code for Leukotome, a class I device type, regulated under 21 CFR 882.4600. As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and one recall.

Classification record

Product code
GXE
Device name
Leukotome
Regulation
21 CFR 882.4600
Device class
Class I
Review panel
Neurology
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
1
Ingested recalls
1

Clearances, product code GXE

By decision year
1 clearance under product code GXE with a decision year between 1992 and 1992, 1992 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code GXE by decision year
YearClearances
19921

Applicants with the most clearances

Product code GXE
Applicants holding the most 510(k) clearances under product code GXE
ApplicantClearances
Dantec Medical, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

No registered establishment in MDM’s records lists product code GXE.