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FDA 510(k)

ClearCam System

K-Number: K200228 · 2020-02-19

ApplicantClearcam, LLC
Decision Date2020-02-19
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ClearCam System is the device name listed in this FDA 510(k) record. The listed applicant is Clearcam, LLC. It received FDA 510(k) clearance on 2020-02-19 under 510(k) number K200228. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ClearCam System?

ClearCam System is a medical device that received FDA 510(k) clearance on 2020-02-19. The listed applicant is Clearcam, LLC. The 510(k) number is K200228.

When did ClearCam System receive FDA 510(k) clearance?

ClearCam System received FDA 510(k) clearance on 2020-02-19, under 510(k) number K200228.

Who is the listed applicant for ClearCam System?

The FDA 510(k) record lists Clearcam, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ClearCam System?

The FDA product code for ClearCam System is GCJ.

Related Devices (Code: GCJ)

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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