KOH · Class I · 21 CFR 884.4520

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

Leading manufacturers include Zinnanti Surgical Instruments, Inc., KARL STORZ Endoscopy-America, Inc. and C.R. Bard, 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 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 Mar 05, 1984
CAT. 4-OBSTETRICS GYNECOLOGY DEV'S
K840308
Imm Enterprises , Ltd.
Obstetrics & Gynecology · 41d
Cleared Dec 07, 1978
INSTRUMENT CURNETT MINI-CONER BIOPSY
K781767
C.R. Bard, Inc.
Obstetrics & Gynecology · 52d

About Product Code KOH - Regulatory Context