FDA 510(k)

gammaCore-S

K-Number: K171306 · 2017-05-30

Decision Date2017-05-30

Product CodePKR

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

gammaCore-S is the device name listed in this FDA 510(k) record. The listed applicant is Electrocore, LLC. It received FDA 510(k) clearance on 2017-05-30 under 510(k) number K171306. The device is classified under product code PKR. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the gammaCore-S?

gammaCore-S is a medical device that received FDA 510(k) clearance on 2017-05-30. The listed applicant is Electrocore, LLC. The 510(k) number is K171306.

When did gammaCore-S receive FDA 510(k) clearance?

gammaCore-S received FDA 510(k) clearance on 2017-05-30, under 510(k) number K171306.

Who is the listed applicant for gammaCore-S?

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

What is the FDA product code for gammaCore-S?

The FDA product code for gammaCore-S is PKR.

Other records listing Electrocore, LLC 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.

K211856gammaCore Sapphire K203546gammaCore Sapphire K191830gammaCore Sapphire K182369gammaCore Sapphire K180538gammaCore Sapphire K173442gammaCore-S

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Related Devices (Code: PKR)

K211856gammaCore SapphireElectrocore, Inc.K203546gammaCore SapphireElectrocore, Inc.K191830gammaCore SapphireElectrocore, Inc.K182369gammaCore SapphireElectrocore, Inc.K180538gammaCore SapphireElectrocore, LLC K173442gammaCore-SElectrocore, LLC

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.