DeviceClearance

Product code HEX— Obstetrics/Gynecology

ACCUSCOPE(TM) & ACCUSCOPE II(TM)

Classification name
Colposcope (And Colpomicroscope)
Device class
Class 2
Regulation
21 CFR 884.1630
Advisory panel
Obstetrics/Gynecology
Total cleared
56
First cleared
Most recent

Market context for product code HEX

FDA has cleared 56 devices under product code HEX between 1976 and 2024, filed by 43 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 HEX

Recent clearances under product code HEX

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