Cleared Traditional

Kitazato OPU Needles

K162881 · Kitazato Corporation · Obstetrics & Gynecology
Jul 2017
Decision
270d
Days
Class 2
Risk

About This 510(k) Submission

K162881 is an FDA 510(k) clearance for the Kitazato OPU Needles, a Needle, Assisted Reproduction (Class II — Special Controls, product code MQE), submitted by Kitazato Corporation (Tokyo, JP). The FDA issued a Cleared decision on July 11, 2017, 270 days after receiving the submission on October 14, 2016. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.6100.

Submission Details

510(k) Number K162881 FDA.gov
FDA Decision Cleared SESE
Date Received October 14, 2016
Decision Date July 11, 2017
Days to Decision 270 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF

Device Classification

Product Code MQE — Needle, Assisted Reproduction
Device Class Class II — Special Controls
CFR Regulation 21 CFR 884.6100

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