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FDA 510(k)

Kitazato OPU Needles

K-Number: K162881 · 2017-07-11

ApplicantKitazato Corporation
Decision Date2017-07-11
Product CodeMQE
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Kitazato OPU Needles is the device name listed in this FDA 510(k) record. The listed applicant is Kitazato Corporation. It received FDA 510(k) clearance on 2017-07-11 under 510(k) number K162881. The device is classified under product code MQE. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Kitazato OPU Needles?

Kitazato OPU Needles is a medical device that received FDA 510(k) clearance on 2017-07-11. The listed applicant is Kitazato Corporation. The 510(k) number is K162881.

When did Kitazato OPU Needles receive FDA 510(k) clearance?

Kitazato OPU Needles received FDA 510(k) clearance on 2017-07-11, under 510(k) number K162881.

Who is the listed applicant for Kitazato OPU Needles?

The FDA 510(k) record lists Kitazato Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Kitazato OPU Needles?

The FDA product code for Kitazato OPU Needles is MQE.

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Related Devices (Code: MQE)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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