DeviceClearance

Product code KXP— Obstetrics/Gynecology

AMIELLE

Classification name
Stent, Vaginal
Device class
Class 2
Regulation
21 CFR 884.3900
Advisory panel
Obstetrics/Gynecology
Total cleared
4
First cleared
Most recent

Market context for product code KXP

FDA has cleared 4 devices under product code KXP between 1995 and 2020, filed by 4 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 KXP

Recent clearances under product code KXP

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