DeviceClearance

Product code PON— Obstetrics/Gynecology

Aqueduct 100 Cervical Dilator

Classification name
Catheter, Balloon, Dilation Of Cervical Canal
Device class
Class 2
Regulation
21 CFR 884.4260
Advisory panel
Obstetrics/Gynecology
Total cleared
4
First cleared
Most recent

FDA classification definition

“Mechanical dilation and softening of the cervix.”

— U.S. Food and Drug Administration, device classification record for product code PON under 21 CFR 884.4260, via openFDA

Market context for product code PON

FDA has cleared 4 devices under product code PON between 2016 and 2021, filed by 2 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 PON

Recent clearances under product code PON

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