Cleared Traditional

UTERINE INJECTOR

K020292 · Catheter Research, Inc. · Obstetrics & Gynecology
Apr 2002
Decision
79d
Days
Class 2
Risk

About This 510(k) Submission

K020292 is an FDA 510(k) clearance for the UTERINE INJECTOR, a Cannula, Manipulator/injector, Uterine (Class II — Special Controls, product code LKF), submitted by Catheter Research, Inc. (Indianapolis, US). The FDA issued a Cleared decision on April 17, 2002, 79 days after receiving the submission on January 28, 2002. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.4530.

Submission Details

510(k) Number K020292 FDA.gov
FDA Decision Cleared SESE
Date Received January 28, 2002
Decision Date April 17, 2002
Days to Decision 79 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Statement

Device Classification

Product Code LKF — Cannula, Manipulator/injector, Uterine
Device Class Class II — Special Controls
CFR Regulation 21 CFR 884.4530

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