Uterine Injector

• • Terminated Z-1077-06 FDA Unclassified (pre-2012) ·initiated 24 Apr 2006

  The uterine stop component was not included with the device.

510(k) Number

K020292 ↗

FDA Product Code

LKF

Device Class

Class II

Regulation

21 CFR Part 884.4530

Advisory Committee

Obstetrics/Gynecology

FDA Decision

SESE Substantially Equivalent

• Intrauterine Insemination (Iui) Catheter

  Class II

  FDA 510(k) K120154 Active Cleared 21 Mar 2012

• Disposable Esophageal Stethoscope

  Class II

  FDA 510(k) K973839 Active Cleared 19 Mar 1998

• Disposable Gas Sampling Lines

  Class II

  FDA 510(k) K946044 Active Cleared 27 Dec 1994

• Uterine Manipulator/Injector

  Class II

  FDA 510(k) K974357 Active Cleared 2 Feb 1998

• H/S Catheter Set

  Class II

  FDA 510(k) K032835 Active Cleared 11 Dec 2003

• The Advance Catheter for Hsg and Sis

  Class II

  FDA 510(k) K123258 Active Cleared 31 Jan 2013

See all devices from Catheter Research, Inc. →