Cleared Traditional

Kitazato ET Catheters

K162878 · Kitazato Corporation · Obstetrics & Gynecology
Jul 2017
Decision
272d
Days
Class 2
Risk

About This 510(k) Submission

K162878 is an FDA 510(k) clearance for the Kitazato ET Catheters, a Catheter, Assisted Reproduction (Class II — Special Controls, product code MQF), submitted by Kitazato Corporation (Tokyo, JP). The FDA issued a Cleared decision on July 13, 2017, 272 days after receiving the submission on October 14, 2016. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.6110.

Submission Details

510(k) Number K162878 FDA.gov
FDA Decision Cleared SESE
Date Received October 14, 2016
Decision Date July 13, 2017
Days to Decision 272 days
Submission Type Traditional
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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