HDG — Speculum, Vaginal, Metal, Fiberoptic Class I

FDA Device Classification

FDA product code HDG covers "Speculum, Vaginal, Metal, Fiberoptic", 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
HDG
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
K864865luxtecSPECULUM, VAGINAL, METAL FIBEROPTICJanuary 9, 1987
K771181welch allynVAGINAL ILLUMINATOR, MODEL 78570July 14, 1977