HDF · Class I · 21 CFR 884.4520

FDA Product Code HDF: Speculum, Vaginal, Metal

Leading manufacturers include Conphar, Inc., Downs Surgical , Ltd. and Zinnanti Surgical Instruments, Inc..

11
Total
11
Cleared
77d
Avg days
1982
Since

FDA 510(k) Cleared Speculum, Vaginal, Metal Devices (Product Code HDF)

11 devices
1–11 of 11
Cleared Feb 28, 1994
VAGINAL SPECULA: CUSCO, GUTTMAN, INFANT
K926429
Thomasville Medical Assoc.
Obstetrics & Gynecology · 432d
Cleared Mar 22, 1989
MIYA SPECULUM
K891041
Zinnanti Surgical Instruments, Inc.
Obstetrics & Gynecology · 22d
Cleared Mar 17, 1989
LASER SPECULA
K891044
Zinnanti Surgical Instruments, Inc.
Obstetrics & Gynecology · 17d
Cleared Feb 13, 1989
VAGINAL SPECULUM
K890375
Kinetic Medical Products
Obstetrics & Gynecology · 21d
Cleared Oct 29, 1985
WELLINGTON HOSPITAL PATTERN SELF RETAINING VAGINAL
K853640
Downs Surgical , Ltd.
Obstetrics & Gynecology · 70d
Cleared May 22, 1985
61-100 TO 61-124 VARIOUS VAGINAL SPECVIA(CUSCO,GRA
K851799
Artiberia
Obstetrics & Gynecology · 27d
Cleared Oct 01, 1984
WELLINGTON HOSPITAL PATTERN SELF-RETAIN
K843388
Downs Surgical , Ltd.
Obstetrics & Gynecology · 33d
Cleared May 24, 1982
PEDERSON VAGINAL SPECULA
K821291
Conphar, Inc.
Obstetrics & Gynecology · 20d
Cleared May 24, 1982
GRAVES SPECULA
K821297
Conphar, Inc.
Obstetrics & Gynecology · 20d

About Product Code HDF - Regulatory Context