DeviceClearance

Product code HDR— Obstetrics/Gynecology

AXCAN SPERM CUP

Classification name
Cap, Cervical
Device class
Class 2
Regulation
21 CFR 884.5250
Advisory panel
Obstetrics/Gynecology
Total cleared
29
First cleared
Most recent

Market context for product code HDR

FDA has cleared 29 devices under product code HDR between 1981 and 2025, filed by 17 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 HDR

Recent clearances under product code HDR

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