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FDA 510(k)

Clear Guide SCENERGY

K-Number: K153004 · 2016-02-12

ApplicantClear Guide Medical
Decision Date2016-02-12
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Clear Guide SCENERGY is the device name listed in this FDA 510(k) record. The listed applicant is Clear Guide Medical. It received FDA 510(k) clearance on 2016-02-12 under 510(k) number K153004. The device is classified under product code JAK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Clear Guide SCENERGY?

Clear Guide SCENERGY is a medical device that received FDA 510(k) clearance on 2016-02-12. The listed applicant is Clear Guide Medical. The 510(k) number is K153004.

When did Clear Guide SCENERGY receive FDA 510(k) clearance?

Clear Guide SCENERGY received FDA 510(k) clearance on 2016-02-12, under 510(k) number K153004.

Who is the listed applicant for Clear Guide SCENERGY?

The FDA 510(k) record lists Clear Guide Medical as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Clear Guide SCENERGY?

The FDA product code for Clear Guide SCENERGY is JAK.

Related Clinical Trials

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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Other records listing Clear Guide Medical as applicant

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.

K234030Clear Guide SCENERGYK201188Clear Guide SCENERGYK201898Clear Guide SCENERGYK171677Clear Guide SCENERGY

Related Devices (Code: JAK)

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

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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