Intran Plus
FDA 510(k) K905563 · Utah Medical Products, Inc.
510(k) numberK905563
Submission
- Device name
- Intran Plus
- Applicant
- Utah Medical Products, Inc.
Midvale, UT, US - Received
- December 12, 1990
- Decision date
- June 19, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KXO – Monitor, Pressure, Intrauterine
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.2700
- Specialty
- Obstetrics/Gynecology
Other 510(k)s with product code KXO
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K991235 | Softrans Temp Intrauterine Pressure Catheter System (Iup 5000, Softrans Temp Iupc)KXO · Traditional | Ludlow Technical Products | 07/08/1999SE |
| K982565 | Easy Trans TipKXO · Traditional | Carl Schuh | 09/22/1998SE |
| K974730 | Softrans Plus Intrauterine Pressure Catheter System (Iup 5000, Softrans Plus Iupc)KXO · Traditional | Graphic Controls Corp. | 07/14/1998SE |
| K964279 | Softrans Intrauterine Pressure Catheter System (Iup 4000 Softrans Iupc)KXO · Traditional | Graphic Controls Corp. | 01/22/1997SE |
| K961290 | Iup - Tip Trans, Iup - Proxi TransKXO · Traditional | Scientific Device Manufacturer, LLC | 10/15/1996SE |
| K950498 | Life Trace Trans Tip Intrauterine Pressure CatheterKXO · Traditional | Graphic Controls Corp. | 07/24/1995SE |
| K950708 | Lifetrace Intrauterine Pressure Catheter Iup 3000KXO · Traditional | Graphic Controls Corp. | 05/25/1995SE |
| K922323 | MX4042/MC4044 Series Simulcath(Tm)KXO · Traditional | Medex, Inc. | 06/14/1994SE |
| K920044 | Dual Lumen Transcerivical Intrauterine KitKXO · Traditional | Telos Medical Corp. | 04/03/1992SE |
| K910742 | Medi-Trace Disposable Intrauterine CatheterKXO · Traditional | Graphic Controls Corp. | 01/14/1992SE |
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| K101535 | Bt-CathOQY · Traditional | 01/11/2011SE |
| K063611 | Saline/ Contrast Media Infusion CatheterLKF · Traditional | 05/23/2007SE |
| K001874 | Peripherally Inserted Central CatheterLJS · Traditional | 09/25/2000SE |
| K000974 | Fowler Endocurette, Model Cur-XxxHHK · Traditional | 05/23/2000SE |
| K965245 | TBDHGI · Traditional | 07/03/1997SE |
| K970077 | Liberty Plus SYSTEM(PFS-300)/VAGINAL Probe, Liberty PLUS(PFS-044)KPI · Traditional | 05/23/1997SE |
| K955663 | Abc In-Line Blood Sampling KitCBT · Traditional | 03/17/1997SE |
| K964526 | Liberty Rectal Pelvic Floor ExerciserKPI · Traditional | 02/10/1997SE |
Questions and answers
When was Intran Plus cleared by the FDA?
Intran Plus (K905563) received a 510(k) decision of Substantially Equivalent on June 19, 1991, 189 days after the submission was received.
What is the product code of K905563?
The FDA product code is KXO – Monitor, Pressure, Intrauterine, a Class II (moderate risk) device regulated under 21 CFR 884.2700.