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FDA 510(k)

GBR system

K-Number: K170697 · 2018-05-24

ApplicantSurgident
Decision Date2018-05-24
Product CodeJEY
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

GBR system is a medical device manufactured by Surgident. It received FDA 510(k) clearance on 2018-05-24 under approval number K170697. The device is classified under product code JEY. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GBR system?

GBR system is a medical device that received FDA 510(k) clearance on 2018-05-24. It is manufactured by Surgident. The 510(k) number is K170697.

When was GBR system approved by the FDA?

GBR system received FDA 510(k) clearance on 2018-05-24, under approval number K170697.

What company makes GBR system?

GBR system is manufactured by Surgident.

What is the FDA product code for GBR system?

The FDA product code for GBR system is JEY.

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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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