Intrauterine Catheter Tip
FDA 510(k) K790678 · Sonicaid, Inc.
510(k) numberK790678
Submission
- Device name
- Intrauterine Catheter Tip
- Applicant
- Sonicaid, Inc.
Mchenry, IL, US - Received
- April 9, 1979
- Decision date
- May 11, 1979
- 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 |
More from Graphic Controls Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K873673 | BV105 (&BV105R) Vascular Flow Detector W/OptionalDPT · Traditional | 02/26/1988SE |
| K872074 | 5 MHZ TransducerJOP · Traditional | 08/25/1987SE |
| K863803 | Vasopulse(Tm)/Model 5000JOM · Traditional | 05/06/1987SE |
| K862720 | VASOFLO-3 & Extravascular Blood Flow ProbesDPW · Traditional | 11/17/1986SE |
| K861237 | Vasoview Duplex Imaging SystemITX · Traditional | 07/14/1986SN |
| K851102 | Vasoscreen Impedance PlethysmographDQB · Traditional | 05/16/1985SE |
| K833902 | VasoscanJOP · Traditional | 01/27/1984SE |
| K832374 | Photoflo Dual-Mode PhotoplethysmographJOM · Traditional | 12/01/1983SE |
| K833488 | SonicompHEM · Traditional | 11/28/1983SE |
| K833227 | Sonicaid Model D206E Air Emboli-DetectLBA · Traditional | 10/27/1983SE |
Questions and answers
When was Intrauterine Catheter Tip cleared by the FDA?
Intrauterine Catheter Tip (K790678) received a 510(k) decision of Substantially Equivalent on May 11, 1979, 32 days after the submission was received.
What is the product code of K790678?
The FDA product code is KXO – Monitor, Pressure, Intrauterine, a Class II (moderate risk) device regulated under 21 CFR 884.2700.