DeviceClearance

Product code HKP— Ophthalmic

AARON VAC 2

Classification name
Instrument, Vitreous Aspiration And Cutting, Battery-Powered
Device class
Class 2
Regulation
21 CFR 886.4150
Advisory panel
Ophthalmic
Total cleared
16
First cleared
Most recent

Market context for product code HKP

FDA has cleared 16 devices under product code HKP between 1976 and 1997, filed by 13 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

Top applicants under product code HKP

Recent clearances under product code HKP

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