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FDA 510(k)

Espire Elbow Pro, Espire Elbow Hybrid

K-Number: K182757 · 2018-11-29

ApplicantCollege Park Industries, Inc.
Decision Date2018-11-29
Product CodeGXY
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Espire Elbow Pro, Espire Elbow Hybrid is a medical device manufactured by College Park Industries, Inc.. It received FDA 510(k) clearance on 2018-11-29 under approval number K182757. The device is classified under product code GXY. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Espire Elbow Pro, Espire Elbow Hybrid?

Espire Elbow Pro, Espire Elbow Hybrid is a medical device that received FDA 510(k) clearance on 2018-11-29. It is manufactured by College Park Industries, Inc.. The 510(k) number is K182757.

When was Espire Elbow Pro, Espire Elbow Hybrid approved by the FDA?

Espire Elbow Pro, Espire Elbow Hybrid received FDA 510(k) clearance on 2018-11-29, under approval number K182757.

What company makes Espire Elbow Pro, Espire Elbow Hybrid?

Espire Elbow Pro, Espire Elbow Hybrid is manufactured by College Park Industries, Inc..

What is the FDA product code for Espire Elbow Pro, Espire Elbow Hybrid?

The FDA product code for Espire Elbow Pro, Espire Elbow Hybrid is GXY.

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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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