HDL — Retractor, Vaginal Class I

FDA Device Classification

FDA product code HDL covers "Retractor, Vaginal", a Class I medical device regulated under 21 CFR 884.4520. 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
HDL
Device Class
Class I
Regulation Number
884.4520
Submission Type
Review Panel
OB
Medical Specialty
Obstetrics/Gynecology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K891038zinnanti surgical instrumentsVAGINAL RETRACTORS - KRISTELLER, DELEE, BREISKYMarch 17, 1989
K780349edward weckVAGINAL RETRACTORMarch 14, 1978