KOH · Class I · 21 CFR 884.4520

FDA Product Code KOH: Instrument, Manual, General Obstetric-gynecologic

Leading manufacturers include Zinnanti Surgical Instruments, Inc., Medikmark, Inc. and KARL STORZ Endoscopy-America, Inc..

15
Total
15
Cleared
159d
Avg days
1978
Since

FDA 510(k) Cleared Instrument, Manual, General Obstetric-gynecologic Devices (Product Code KOH)

15 devices
1–15 of 15
Cleared Apr 21, 2000
KSEA CHARDONNES MORCELLATION KNIFE
K000212
KARL STORZ Endoscopy-America, Inc.
Obstetrics & Gynecology · 88d
Cleared Jun 15, 1994
C-SECTION PACK
K921730
Medikmark, Inc.
Obstetrics & Gynecology · 796d
Cleared Jun 15, 1994
MINOR LAP SET
K921732
Medikmark, Inc.
Obstetrics & Gynecology · 796d
Cleared May 11, 1989
NEWPORT LATERAL VAGINAL RETRACTOR
K891351
Simpson/Basye, Inc.
Obstetrics & Gynecology · 62d
Cleared May 11, 1989
VAGINAL SPECULA: CUSCO, GUTTMAN, INFANT
K892693
Zinnanti Surgical Instruments, Inc.
Obstetrics & Gynecology · 28d
Cleared Mar 22, 1989
NEEDLE EXTENSIONS
K891035
Zinnanti Surgical Instruments, Inc.
Obstetrics & Gynecology · 22d
Cleared Mar 17, 1989
ZEPPELIN SCISSORS
K891049
Zinnanti Surgical Instruments, Inc.
Obstetrics & Gynecology · 17d
Cleared Jan 07, 1987
THE OB-GYN CONCEPTS VAGINAL ASPIRATOR
K863610
Ob/Gyn Concepts, Ltd.
Obstetrics & Gynecology · 113d
Cleared Mar 05, 1984
CAT. 4-OBSTETRICS GYNECOLOGY DEV'S
K840308
Imm Enterprises , Ltd.
Obstetrics & Gynecology · 41d
Cleared Jan 18, 1983
QUARTZ RETRACTOR/PROBE
K823792
American V. Mueller
Obstetrics & Gynecology · 34d
Cleared Oct 13, 1981
UTERINE MANIPULATORS
K812204
Reznik Instruments
Obstetrics & Gynecology · 70d
Cleared Jun 30, 1980
SER-TEX
K800834
V.S.S.I., Inc.
Obstetrics & Gynecology · 77d
Cleared Jul 30, 1979
VAGI-PRESS #401
K790851
C. Intl.
Obstetrics & Gynecology · 87d
Cleared Dec 07, 1978
INSTRUMENT CURNETT MINI-CONER BIOPSY
K781767
C.R. Bard, Inc.
Obstetrics & Gynecology · 52d
Cleared Jun 28, 1978
DENTAL AIR BRUSH
K780460
M. Joel Gebhart, D.D.S.
Obstetrics & Gynecology · 98d

About Product Code KOH - Regulatory Context