DeviceClearance

Product code HGS— Obstetrics/Gynecology

INTRAUTERINE CATHETER SET

Classification name
Catheter, Intrauterine And Introducer
Device class
Class 2
Regulation
21 CFR 884.2700
Advisory panel
Obstetrics/Gynecology
Total cleared
2
First cleared
Most recent

Market context for product code HGS

FDA has cleared 2 devices under product code HGS, all in 1991, 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.

Top applicants under product code HGS

Recent clearances under product code HGS

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