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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 the device name listed in this FDA 510(k) record. The listed applicant is College Park Industries, Inc.. It received FDA 510(k) clearance on 2018-11-29 under 510(k) 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. The listed applicant is College Park Industries, Inc.. The 510(k) number is K182757.

When did Espire Elbow Pro, Espire Elbow Hybrid receive FDA 510(k) clearance?

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

Who is the listed applicant for Espire Elbow Pro, Espire Elbow Hybrid?

The FDA 510(k) record lists College Park Industries, Inc. as the applicant. This does not by itself establish the device manufacturer.

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.

Related Devices (Code: GXY)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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