Iup - Tip Trans, Iup - Proxi Trans

FDA 510(k) K961290 · Scientific Device Manufacturer, LLC

Substantially Equivalent

510(k) numberK961290

Submission

Device name
Iup - Tip Trans, Iup - Proxi Trans
Applicant
Scientific Device Manufacturer, LLC
San Rafael, CA, US
Received
April 4, 1996
Decision date
October 15, 1996
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

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)DeviceApplicantDecision
K991235Softrans Temp Intrauterine Pressure Catheter System (Iup 5000, Softrans Temp Iupc)KXO · Traditional Ludlow Technical Products07/08/1999SE
K982565Easy Trans TipKXO · Traditional Carl Schuh09/22/1998SE
K974730Softrans Plus Intrauterine Pressure Catheter System (Iup 5000, Softrans Plus Iupc)KXO · Traditional Graphic Controls Corp.07/14/1998SE
K964279Softrans Intrauterine Pressure Catheter System (Iup 4000 Softrans Iupc)KXO · Traditional Graphic Controls Corp.01/22/1997SE
K950498Life Trace Trans Tip Intrauterine Pressure CatheterKXO · Traditional Graphic Controls Corp.07/24/1995SE
K950708Lifetrace Intrauterine Pressure Catheter Iup 3000KXO · Traditional Graphic Controls Corp.05/25/1995SE
K922323MX4042/MC4044 Series Simulcath(Tm)KXO · Traditional Medex, Inc.06/14/1994SE
K920044Dual Lumen Transcerivical Intrauterine KitKXO · Traditional Telos Medical Corp.04/03/1992SE
K910742Medi-Trace Disposable Intrauterine CatheterKXO · Traditional Graphic Controls Corp.01/14/1992SE
K905563Intran PlusKXO · Traditional Utah Medical Products, Inc.06/19/1991SE

More from Utah Medical Products, Inc.

510(k)DeviceDecision
K960764Safe-CathFOZ · Traditional 04/24/1997SE
K960431Pressure Stopcock/ManifoldFPA · Traditional 10/29/1996SE
K960430Control SyringeDXT · Traditional 08/06/1996SE
K960917PercuglideDRE · Traditional 07/02/1996SE
K952579Toco TransducerHFM · Traditional 08/04/1995SE

Questions and answers

When was Iup - Tip Trans, Iup - Proxi Trans cleared by the FDA?

Iup - Tip Trans, Iup - Proxi Trans (K961290) received a 510(k) decision of Substantially Equivalent on October 15, 1996, 194 days after the submission was received.

What is the product code of K961290?

The FDA product code is KXO – Monitor, Pressure, Intrauterine, a Class II (moderate risk) device regulated under 21 CFR 884.2700.