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FDA 510(k)

GDT-1000 System

K-Number: K180096 · 2018-04-16

ApplicantAcuvu, Inc.
Decision Date2018-04-16
Product CodeHIH
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

GDT-1000 System is a medical device manufactured by Acuvu, Inc.. It received FDA 510(k) clearance on 2018-04-16 under approval number K180096. The device is classified under product code HIH. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GDT-1000 System?

GDT-1000 System is a medical device that received FDA 510(k) clearance on 2018-04-16. It is manufactured by Acuvu, Inc.. The 510(k) number is K180096.

When was GDT-1000 System approved by the FDA?

GDT-1000 System received FDA 510(k) clearance on 2018-04-16, under approval number K180096.

What company makes GDT-1000 System?

GDT-1000 System is manufactured by Acuvu, Inc..

What is the FDA product code for GDT-1000 System?

The FDA product code for GDT-1000 System is HIH.

Other Devices by Acuvu, Inc.

K211227HTx Disposable Hysteroscope System

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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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