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

Strip, Craniosynostosis, Preformed

21 CFR 882.5900 / Neurology
FDA source (opens on fda.gov)

GXO is the FDA product code for Strip, Craniosynostosis, Preformed, a class II device type, regulated under 21 CFR 882.5900. As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
GXO
Device name
Strip, Craniosynostosis, Preformed
Regulation
21 CFR 882.5900
Device class
Class II
Review panel
Neurology
Submission type
510(k)
Implant
Yes
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
2
Ingested recalls
0

Clearances, product code GXO

By decision year
2 clearances under product code GXO with a decision year between 1996 and 2004, 1996 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code GXO by decision year
YearClearances
19961
20041

Applicants with the most clearances

Product code GXO
Applicants holding the most 510(k) clearances under product code GXO
ApplicantClearances
Cerenovus, Inc.1
W. L. Gore & Associates, 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 GXO.