KXO · Class II · 21 CFR 884.2700

FDA Product Code KXO: Monitor, Pressure, Intrauterine

Leading manufacturers include Graphic Controls Corp., Medex, Inc. and Utah Medical Products, Inc..

26
Total
26
Cleared
139d
Avg days
1979
Since

FDA 510(k) Cleared Monitor, Pressure, Intrauterine Devices (Product Code KXO)

26 devices
1–24 of 26
Cleared Jul 14, 1998
SOFTRANS PLUS INTRAUTERINE PRESSURE CATHETER SYSTEM (IUP 5000, SOFTRANS PLUS IUPC)
K974730
Graphic Controls Corp.
Obstetrics & Gynecology · 208d
Cleared Jan 22, 1997
SOFTRANS INTRAUTERINE PRESSURE CATHETER SYSTEM (IUP 4000 SOFTRANS IUPC)
K964279
Graphic Controls Corp.
Obstetrics & Gynecology · 86d
Cleared Jul 24, 1995
LIFE TRACE TRANS TIP INTRAUTERINE PRESSURE CATHETER
K950498
Graphic Controls Corp.
Obstetrics & Gynecology · 168d
Cleared May 25, 1995
LIFETRACE INTRAUTERINE PRESSURE CATHETER IUP 3000
K950708
Graphic Controls Corp.
Obstetrics & Gynecology · 101d
Cleared Jun 14, 1994
MX4042/MC4044 SERIES SIMULCATH(TM)
K922323
Medex, Inc.
Obstetrics & Gynecology · 771d
Cleared Jan 14, 1992
MEDI-TRACE DISPOSABLE INTRAUTERINE CATHETER
K910742
Graphic Controls Corp.
Obstetrics & Gynecology · 327d
Cleared Jun 19, 1991
INTRAN PLUS
K905563
Utah Medical Products, Inc.
Obstetrics & Gynecology · 189d
Cleared Apr 03, 1991
MX4043---SERIES, INTRAUTERINE PRESSURE CATHETER
K910227
Medex, Inc.
Obstetrics & Gynecology · 75d
Cleared Mar 23, 1989
DISPOSABLE INTRAUTERINE PRESSURE KIT MODEL 13972A
K885316
Hewlett-Packard Co.
Obstetrics & Gynecology · 84d
Cleared Feb 26, 1987
IUC - INTRAUTERINE CATHETER
K862873
Utah Medical Products, Inc.
Obstetrics & Gynecology · 211d
Cleared Apr 14, 1986
MX4040 INTRAUTERINE PRESSURE MONITORING KIT
K860101
Medex, Inc.
Obstetrics & Gynecology · 94d
Cleared Mar 21, 1979
MODEL 8100 PRE-FILLED INTRAUTERINE
K790418
Ge Medical Systems Information Technologies
Radiology · 21d

About Product Code KXO - Regulatory Context