DeviceClearance

Product code HIS— Obstetrics/Gynecology

CONDOM

Classification name
Condom
Device class
Class 2
Regulation
21 CFR 884.5300
Advisory panel
Obstetrics/Gynecology
Total cleared
401
First cleared
Most recent

Market context for product code HIS

FDA has cleared 401 devices under product code HIS between 1977 and 2026, filed by 177 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 HIS

Recent clearances under product code HIS

1–100 of 401

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