HHO — Screw, Fibroid, Gynecological Class II

FDA Device Classification

FDA product code HHO covers "Screw, Fibroid, Gynecological", a Class II medical device regulated under 21 CFR 884.4530. Submissions are reviewed by the Obstetrics/Gynecology panel. At least 2 recent 510(k) clearances have been granted under this product code.

Classification Details

Product Code
HHO
Device Class
Class II
Regulation Number
884.4530
Submission Type
Review Panel
OB
Medical Specialty
Obstetrics/Gynecology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K915412cook urologicalHYSTEROSCOPIC MYOMA SCREWMay 18, 1992
K915388cook urologicalLAPAROCOPIC MYOMA SCREWMay 18, 1992