Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Kitazato OPU Needles

K-Number: K162881 · 2017-07-11

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

Device Summary

Kitazato OPU Needles is a medical device manufactured by Kitazato Corporation. It received FDA 510(k) clearance on 2017-07-11 under approval 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. It is manufactured by Kitazato Corporation. The 510(k) number is K162881.

When was Kitazato OPU Needles approved by the FDA?

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

What company makes Kitazato OPU Needles?

Kitazato OPU Needles is manufactured by Kitazato Corporation.

What is the FDA product code for Kitazato OPU Needles?

The FDA product code for Kitazato OPU Needles is MQE.

Other Devices by Kitazato Corporation

View all 13 devices →

Related Devices (Code: MQE)

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.