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FDA 510(k)

ORIGIO Gradient 100, ORIGIO Gradient 90, ORIGIO Gradient 40/80, ORIGIO Sperm Wash

K-Number: K153267 · 2016-07-22

ApplicantOrigio A/S
Decision Date2016-07-22
Product CodeMQL
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

ORIGIO Gradient 100, ORIGIO Gradient 90, ORIGIO Gradient 40/80, ORIGIO Sperm Wash is a medical device manufactured by Origio A/S. It received FDA 510(k) clearance on 2016-07-22 under approval number K153267. The device is classified under product code MQL. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ORIGIO Gradient 100, ORIGIO Gradient 90, ORIGIO Gradient 40/80, ORIGIO Sperm Wash?

ORIGIO Gradient 100, ORIGIO Gradient 90, ORIGIO Gradient 40/80, ORIGIO Sperm Wash is a medical device that received FDA 510(k) clearance on 2016-07-22. It is manufactured by Origio A/S. The 510(k) number is K153267.

When was ORIGIO Gradient 100, ORIGIO Gradient 90, ORIGIO Gradient 40/80, ORIGIO Sperm Wash approved by the FDA?

ORIGIO Gradient 100, ORIGIO Gradient 90, ORIGIO Gradient 40/80, ORIGIO Sperm Wash received FDA 510(k) clearance on 2016-07-22, under approval number K153267.

What company makes ORIGIO Gradient 100, ORIGIO Gradient 90, ORIGIO Gradient 40/80, ORIGIO Sperm Wash?

ORIGIO Gradient 100, ORIGIO Gradient 90, ORIGIO Gradient 40/80, ORIGIO Sperm Wash is manufactured by Origio A/S.

What is the FDA product code for ORIGIO Gradient 100, ORIGIO Gradient 90, ORIGIO Gradient 40/80, ORIGIO Sperm Wash?

The FDA product code for ORIGIO Gradient 100, ORIGIO Gradient 90, ORIGIO Gradient 40/80, ORIGIO Sperm Wash is MQL.

Related Clinical Trials

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Related Devices (Code: MQL)

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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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