FDA Product Code HBI: Illuminator, Fiberoptic, Surgical Field
Leading manufacturers include Olympus Winter & Ibe GmbH.
28
Total
28
Cleared
74d
Avg days
1981
Since
Declining activity -
0 submissions in the last 2 years
vs 1 in the prior period
FDA 510(k) Cleared Illuminator, Fiberoptic, Surgical Field Devices (Product Code HBI)
28 devices
About Product Code HBI - Regulatory Context
510(k) Submission Activity
28 total 510(k) submissions under product code HBI since 1981, with 28 receiving FDA clearance (average review time: 74 days).
Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.
HBI devices are reviewed by the General & Plastic Surgery panel. Browse all General & Plastic Surgery devices →