HIC · Class II · 21 CFR 884.4530

FDA Product Code HIC: Speculum, Vaginal, Nonmetal, Fiberoptic

Leading manufacturers include Tri-State Hospital Supply Corp., Sims Surgical, Inc. and Galenica Enterprises, Inc..

5
Total
5
Cleared
227d
Avg days
1985
Since

FDA 510(k) Cleared Speculum, Vaginal, Nonmetal, Fiberoptic Devices (Product Code HIC)

5 devices
1–5 of 5
Cleared Mar 21, 1996
PAP PLUS SPECULOSCOPY COMPREHENSIVE PELVIC EXAM TRAY
K955790
Trylon Corp.
Obstetrics & Gynecology · 90d
Cleared Sep 08, 1994
LIGHTING SOURCE SYSTEM
K923656
Galenica Enterprises, Inc.
Obstetrics & Gynecology · 787d
Cleared Jul 03, 1990
NEW LENGTH SUGITA APPLIERS
K902516
Sims Surgical, Inc.
Obstetrics & Gynecology · 26d
Cleared Mar 16, 1990
CENTURION VAGINAL SPECULUM
K897100
Tri-State Hospital Supply Corp.
Obstetrics & Gynecology · 85d

About Product Code HIC - Regulatory Context