Cleared Abbreviated

INTRAUTERINE INSEMINATION (IUI) CATHETER

K120154 · Catheter Research, Inc. · Obstetrics & Gynecology
Mar 2012
Decision
63d
Days
Class 2
Risk

About This 510(k) Submission

K120154 is an FDA 510(k) clearance for the INTRAUTERINE INSEMINATION (IUI) CATHETER, a Catheter, Assisted Reproduction (Class II — Special Controls, product code MQF), submitted by Catheter Research, Inc. (Indianapolis, US). The FDA issued a Cleared decision on March 21, 2012, 63 days after receiving the submission on January 18, 2012. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.6110.

Submission Details

510(k) Number K120154 FDA.gov
FDA Decision Cleared SESE
Date Received January 18, 2012
Decision Date March 21, 2012
Days to Decision 63 days
Submission Type Abbreviated
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF

Device Classification

Product Code MQF — Catheter, Assisted Reproduction
Device Class Class II — Special Controls
CFR Regulation 21 CFR 884.6110

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