Product code HHO— Obstetrics/Gynecology

HYSTEROSCOPIC MYOMA SCREW

Classification name
Screw, Fibroid, Gynecological
Device class
Class 2
Regulation
21 CFR 884.4530
Advisory panel
Obstetrics/Gynecology
Total cleared
2
First cleared
Most recent

Market context for product code HHO

FDA has cleared 2 devices under product code HHO, all in 1992, filed by 1 applicant company. 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 HHO

Recent clearances under product code HHO

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