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

Chair, Neurosurgical

21 CFR 882.4125 / Neurology
FDA source (opens on fda.gov)

HBN is the FDA product code for Chair, Neurosurgical, a class I device type, regulated under 21 CFR 882.4125. As of , FDA records hold 4 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
HBN
Device name
Chair, Neurosurgical
Regulation
21 CFR 882.4125
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
4
Ingested recalls
0

Clearances, product code HBN

By decision year
4 clearances under product code HBN with a decision year between 1982 and 1990, 1982 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code HBN by decision year
YearClearances
19823
19901

Applicants with the most clearances

Product code HBN
Applicants holding the most 510(k) clearances under product code HBN
ApplicantClearances
Surgi-Quip Inc.U2
Kelleher Corp.1
Skytron, LLC1

Companies listing this code with FDA

Companies whose registered establishments list this code