Electrocore Inc

FDA Filings

This page includes the latest FDA filings for Electrocore Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

USANASDAQECORDUNS 831341628
FDA Registration(s)
Registration Number3009060963
FEI Number3009060963
NameELECTROCORE LLC
Owner & OperatorElectroCore, Inc.
Contact Address150 Allen Road Suite 201
Basking Ridge NJ 07920 US
Official Correspondent
  • Michael Romaniw
  • x-973-3556702-x
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address150 Allen Rd Ste 201
Basking Ridge, NJ 07920 US
Establishment TypeComplaint File Establishment per 21 CFR 820.198

Registration Number3015529603
FEI Number3015529603
NameELECTROCORE, INC.
Owner & OperatorElectroCore, Inc.
Contact Address150 Allen Road Suite 201
Basking Ridge NJ 07920 US
Official Correspondent
  • Michael Romaniw
  • x-973-3556702-x
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address200 Forge Way Suite 205
Rockaway, NJ 07866 US
Establishment TypeManufacture Medical Device

FDA Filings

Device
Company
DeviceDate
electroCore, Inc.
 gammaCore Sapphire AC Power Adapter 20016-00001-RPL2026-02-05
electroCore, Inc.
 gammaCore Emerald Replacement USB Cable 12116-04903-RPL2026-01-22
electroCore, Inc.
 gammaCore Emerald Replacement Charging Pad 12116-04902-RPL2026-01-22
electroCore, Inc.
 gammaCore Emerald Handset - Replacement 12116-04901-RPL2026-01-22
electroCore, Inc.
 gammaCore 12-Month Card 12116-04512-C2026-01-22
electroCore, Inc.
 gammaCore 3-Month Card 12116-04503-C2026-01-22
electroCore, Inc.
 gammaCore 1-Month Card 12116-04501-C2026-01-22
electroCore, Inc.
 gammaCore Emerald 36-Month Licensed Device Kit 13116-040362026-01-22
electroCore, Inc.
 gammaCore Emerald 12-Month Licensed Device Kit 13116-040122026-01-22
electroCore, Inc.
 gammaCore Emerald 3-Month Licensed Device Kit 13116-040032026-01-22
electroCore, Inc.
 gammaCore Emerald 1-Month Licensed Device Kit 13116-040012026-01-22
electroCore, Inc.
 gammaCore 6-Month Evaluation Refill Kit 11116-045062026-01-22
electroCore, Inc.
 gammaCore 12-Month Refill Kit 12116-045122026-01-22
electroCore, Inc.
 gammaCore 3-Month Refill Kit 12116-045032026-01-22
electroCore, Inc.
 gammaCore 1-Month Refill Kit 12116-045012026-01-22
electroCore, Inc.
 gammaCore Emerald 6-Month Evaluation Device Kit 11116-040062026-01-22
electroCore, Inc.
 gammaCore Emerald-D Device Kit 12116-040362026-01-22
electroCore, Inc.
 gammaCore Emerald 12-Month Device Kit 12116-040122026-01-22
electroCore, Inc.
 gammaCore Emerald 3-Month Device Kit 12116-040032026-01-22
electroCore, Inc.
 gammaCore-S 250 11009-400012025-12-18
electroCore, Inc.
 gammaCore Sapphire D 11016-403052025-12-18
electroCore, Inc.
 gammaCore Sapphire D 11016-403042025-12-18
electroCore, Inc.
 gammaCore Sapphire D 11016-403032025-12-18
electroCore, Inc.
 gammaCore Sapphire D 11016-403022025-12-18
Electrocore, Inc.
GammaCore Sapphire2021-09-10
Electrocore, Inc.
GammaCore Sapphire2021-02-12
Electrocore, Inc.
GammaCore Sapphire2020-03-26
ELECTROCORE, INC.
gammaCore Sapphire2019-05-03
ELECTROCORE, INC.
gammaCore Sapphire2019-05-03
ELECTROCORE, INC.
gammaCore-S2019-05-03
ELECTROCORE, INC.
gammaCore-S2019-05-03
ELECTROCORE, INC.
gammaCore-22019-05-03
Electrocore, Inc.
GammaCore Sapphire2018-11-27
ELECTROCORE, INC.
gammaCore-S2017-06-28
ELECTROCORE, INC.
gammaCore-22017-06-28
ELECTROCORE, INC.
gammaCore Sapphire2017-06-28
ELECTROCORE LLC [ElectroCore, Inc.]
gammaCore-S2017-06-28
ELECTROCORE LLC [ElectroCore, Inc.]
gammaCore-22017-06-28
ELECTROCORE LLC [ElectroCore, Inc.]
gammaCore Sapphire2017-06-28
ELECTROCORE, INC.
gammaCore2017-06-28
ELECTROCORE LLC [ElectroCore, Inc.]
gammaCore2017-06-28

Related Finance Registrations
NCAGE Code5M9C3ELECTROCORE, INC.
CAGE Code5M9C3ELECTROCORE, INC.
S.A.M. Registration5M9C3 [831341628]ELECTROCORE, INC.
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