FDA Product Code
FDA Product Code KXO — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Obstetrics/Gynecology
- 21 CFR Citation
- 884.2700
510(k) Clearances — 26 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K991235 | SOFTRANS TEMP INTRAUTERINE PRESSURE CATHETER SYSTEM (IUP 5000, SOFTRANS TEMP IUPC) | Ludlow Technical Products | 1999-07-08 | Traditional | PDF ↗ |
| K982565 | EASY TRANS TIP | Carl Schuh | 1998-09-22 | Traditional | PDF ↗ |
| K974730 | SOFTRANS PLUS INTRAUTERINE PRESSURE CATHETER SYSTEM (IUP 5000, SOFTRANS PLUS IUPC) | Graphic Controls Corp. | 1998-07-14 | Traditional | PDF ↗ |
| K964279 | SOFTRANS INTRAUTERINE PRESSURE CATHETER SYSTEM (IUP 4000 SOFTRANS IUPC) | Graphic Controls Corp. | 1997-01-22 | Traditional | PDF ↗ |
| K961290 | IUP - TIP TRANS, IUP - PROXI TRANS | Scientific Device Manufacturer, LLC | 1996-10-15 | Traditional | PDF ↗ |
| K950498 | LIFE TRACE TRANS TIP INTRAUTERINE PRESSURE CATHETER | Graphic Controls Corp. | 1995-07-24 | Traditional | PDF ↗ |
| K950708 | LIFETRACE INTRAUTERINE PRESSURE CATHETER IUP 3000 | Graphic Controls Corp. | 1995-05-25 | Traditional | PDF ↗ |
| K922323 | MX4042/MC4044 SERIES SIMULCATH(TM) | Medex, Inc. | 1994-06-14 | Traditional | PDF ↗ |
| K920044 | DUAL LUMEN TRANSCERIVICAL INTRAUTERINE KIT | Telos Medical Corp. | 1992-04-03 | Traditional | PDF ↗ |
| K910742 | MEDI-TRACE DISPOSABLE INTRAUTERINE CATHETER | Graphic Controls Corp. | 1992-01-14 | Traditional | PDF ↗ |
| K905563 | INTRAN PLUS | Utah Medical Products, Inc. | 1991-06-19 | Traditional | PDF ↗ |
| K910227 | MX4043---SERIES, INTRAUTERINE PRESSURE CATHETER | Medex, Inc. | 1991-04-03 | Traditional | PDF ↗ |
| K901084 | ISOFLO INTRAUTERINE PRESSURE MONITORING & AMNIO. | Healthdyne Cardiovascular, Inc. | 1990-06-01 | Traditional | PDF ↗ |
| K896122 | AMNICATHDL(TM) DT-IUPC2 DUAL LUMEN TRANS. TIPPED | Spectramed, Inc. | 1990-01-19 | Traditional | PDF ↗ |
| K895763 | ISOFLO AND ISOTEC INTRAUTERINE PRESSURE MONITORING | Healthdyne Cardiovascular, Inc. | 1989-12-22 | Traditional | PDF ↗ |
| K895323 | MODEL DT-BAL, BALANCE SAVER | Spectramed, Inc. | 1989-10-24 | Traditional | PDF ↗ |
| K894362 | MODEL DT-IUPC2 TRANSDUCER TIPPED DUAL LUMEN IUP | Spectramed, Inc. | 1989-08-15 | Traditional | PDF ↗ |
| K885316 | DISPOSABLE INTRAUTERINE PRESSURE KIT MODEL 13972A | Hewlett-Packard Co. | 1989-03-23 | Traditional | PDF ↗ |
| K881857 | AMNICATH(TM) MODEL DT-IUPC TRANS. TIPPED INTRAU. | Spectramed, Inc. | 1989-02-01 | Traditional | PDF ↗ |
| K883832 | CATHETER, INTRAUTERINE AND INTRODUCER | Telos Medical Corp. | 1988-12-13 | Traditional | PDF ↗ |
| K862873 | IUC - INTRAUTERINE CATHETER | Utah Medical Products, Inc. | 1987-02-26 | Traditional | PDF ↗ |
| K862182 | AMNIOINFUSION CATHETER | Michael Reese Hospital and Medical Center | 1986-08-25 | Traditional | PDF ↗ |
| K860101 | MX4040 INTRAUTERINE PRESSURE MONITORING KIT | Medex, Inc. | 1986-04-14 | Traditional | PDF ↗ |
| K801758 | MMI/GAELTEC CATHETER INTRAUTERINE | Medical Measurements, Inc. | 1980-08-14 | Traditional | PDF ↗ |
| K790678 | INTRAUTERINE CATHETER TIP | Sonicaid, Inc. | 1979-05-11 | Traditional | PDF ↗ |
| K790418 | MODEL 8100 PRE-FILLED INTRAUTERINE | Ge Medical Systems Information Technologies | 1979-03-21 | Traditional | PDF ↗ |
Product code KXO · Class II · Obstetrics/Gynecology. Data: openFDA.