FDA 510(k)

GC Reline II

K-Number: K153253 · 2016-03-03

Decision Date2016-03-03

Product CodeEBI

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

GC Reline II is a medical device manufactured by GC America, Inc.. It received FDA 510(k) clearance on 2016-03-03 under approval number K153253. The device is classified under product code EBI. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GC Reline II?

GC Reline II is a medical device that received FDA 510(k) clearance on 2016-03-03. It is manufactured by GC America, Inc.. The 510(k) number is K153253.

When was GC Reline II approved by the FDA?

GC Reline II received FDA 510(k) clearance on 2016-03-03, under approval number K153253.

What company makes GC Reline II?

GC Reline II is manufactured by GC America, Inc..

What is the FDA product code for GC Reline II?

The FDA product code for GC Reline II is EBI.

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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.