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FDA 510(k)

GC70

K-Number: K163115 · 2016-12-07

Decision Date2016-12-07
Product CodeKPR
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

GC70 is the device name listed in this FDA 510(k) record. The listed applicant is Samsung Electronics Co., Ltd.. It received FDA 510(k) clearance on 2016-12-07 under 510(k) number K163115. The device is classified under product code KPR. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GC70?

GC70 is a medical device that received FDA 510(k) clearance on 2016-12-07. The listed applicant is Samsung Electronics Co., Ltd.. The 510(k) number is K163115.

When did GC70 receive FDA 510(k) clearance?

GC70 received FDA 510(k) clearance on 2016-12-07, under 510(k) number K163115.

Who is the listed applicant for GC70?

The FDA 510(k) record lists Samsung Electronics Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GC70?

The FDA product code for GC70 is KPR.

Other records listing Samsung Electronics Co., Ltd. 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.

View all 25 devices →

Related Devices (Code: KPR)

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.

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.