Home / 510(k) Clearances / K922323

510(k) K922323

MX4042/MC4044 SERIES SIMULCATH(TM) by Medex, Inc. — Product Code KXO

K922323 is an FDA 510(k) premarket notification submitted by Medex, Inc. for the device "MX4042/MC4044 SERIES SIMULCATH(TM)". The FDA issued a decision of Substantially Equivalent on June 14, 1994. The device falls under product code KXO (Monitor, Pressure, Intrauterine), a Class II device regulated under 21 CFR 884.2700. Medex, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 14, 1994
Date Received
May 4, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor, Pressure, Intrauterine
Device Class
Class II
Regulation Number
884.2700
Review Panel
OB
Submission Type

Other clearances by Medex, Inc.

  • K242255 — Qitexio® 4-Way Stopcock (QIT014) (April 29, 2025)
  • K203738 — Qitexio (March 14, 2022)
  • K042432 — PHARMGUARD TOOLBOX, MODEL G6000782 (January 4, 2005)
  • K040899 — MEDEX 3000 SERIES MR SYRINGE INFUSION PUMP (April 30, 2004)
  • K020780 — TRANSTAR INTRACRANIAL PRESSURE TRANSDUCER, MODEL MX950ICP (May 20, 2002)
  • K000328 — MEDEX 3000 SERIES MRI COMPATIBLE SYRINGE INFUSION PUMP (May 9, 2000)
  • K982640 — MEDEX 3000 SERIES SYRINGE INFUSION PUMP (April 6, 1999)
  • K982123 — CONTRAST CONTROL DEVICE (July 21, 1998)
  • K955231 — MEDFUSION MODEL 2001 SYRINGE INFUSION PUMP (July 18, 1996)
  • K961404 — MX960 REUSABLE PRESSURE TRANSDUCER (June 27, 1996)

Other clearances for product code KXO

  • K991235 — SOFTRANS TEMP INTRAUTERINE PRESSURE CATHETER SYSTEM (IUP 5000, SOFTRANS TEMP IUP (July 8, 1999)
  • K982565 — EASY TRANS TIP (September 22, 1998)
  • K974730 — SOFTRANS PLUS INTRAUTERINE PRESSURE CATHETER SYSTEM (IUP 5000, SOFTRANS PLUS IUP (July 14, 1998)
  • K964279 — SOFTRANS INTRAUTERINE PRESSURE CATHETER SYSTEM (IUP 4000 SOFTRANS IUPC) (January 22, 1997)
  • K961290 — IUP - TIP TRANS, IUP - PROXI TRANS (October 15, 1996)
  • K950498 — LIFE TRACE TRANS TIP INTRAUTERINE PRESSURE CATHETER (July 24, 1995)
  • K950708 — LIFETRACE INTRAUTERINE PRESSURE CATHETER IUP 3000 (May 25, 1995)
  • K920044 — DUAL LUMEN TRANSCERIVICAL INTRAUTERINE KIT (April 3, 1992)
  • K910742 — MEDI-TRACE DISPOSABLE INTRAUTERINE CATHETER (January 14, 1992)
  • K905563 — INTRAN PLUS (June 19, 1991)

FDA data resources