DeviceClearance

Product code HDW— Obstetrics/Gynecology

CAYA CONTOURED DIAPHRAGM

Classification name
Diaphragm, Contraceptive (And Accessories)
Device class
Class 2
Regulation
21 CFR 884.5350
Advisory panel
Obstetrics/Gynecology
Total cleared
4
First cleared
Most recent

Market context for product code HDW

FDA has cleared 4 devices under product code HDW between 1980 and 2014, 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 HDW

Recent clearances under product code HDW

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