HFD — Washer, Endometrial Class II

FDA Device Classification

FDA product code HFD covers "Washer, Endometrial", a Class II medical device regulated under 21 CFR 884.1185. Submissions are reviewed by the Obstetrics/Gynecology panel. At least 3 recent 510(k) clearances have been granted under this product code.

Classification Details

Product Code
HFD
Device Class
Class II
Regulation Number
884.1185
Submission Type
Review Panel
OB
Medical Specialty
Obstetrics/Gynecology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K891037zinnanti surgical instrumentsWEIGHTED SPECULA-STEINER,HENROTIN,BERLAND,GARRIGUEMarch 17, 1989
K890376kinetic medical productsVAGINAL SPECULUMFebruary 27, 1989
K810558associated medical productsSKIN SCRUB TRAYMarch 17, 1981