DeviceClearance

Product code HBI— General, Plastic Surgery

ENDOSCOPIC FIBEROPTIC CABLE

Classification name
Illuminator, Fiberoptic, Surgical Field
Device class
Class 2
Regulation
21 CFR 878.4580
Advisory panel
General, Plastic Surgery
Total cleared
28
First cleared
Most recent

Market context for product code HBI

FDA has cleared 28 devices under product code HBI between 1981 and 2023, filed by 18 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

last 15 years

Top applicants under product code HBI

Recent clearances under product code HBI

Data sourced from openFDA. This site is unofficial and independent of the FDA.