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510(k) K242618

Device
Layer 7-T
Applicant
Precision Neuroscience, Corp.
510(k) number
K242618
Product code
GYC
Decision
Substantially Equivalent (SESE)
Decision date
2025-03-30
Date received
2024-09-03
Regulation
882.1310
Classification name
Electrode, Cortical
Medical specialty
Neurology
Review panel
Neurology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
Shruti Jayakumar
Address
319 N Bernardo Ave., Suite 157 Mountain View CA US 94043 94043

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code GYC#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
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K183437AirRay Subdural Cortical ElectrodesCortec GmbH2019-03-12
K180761SD LTM STIM Cortical StimulatorMicromed S.P.A.2018-06-18
K173684g.Estim PROG.Tec Medical Engineering GmbH2018-05-04
K151354Cervello STIMBlackrock Neuromed2016-01-27
K110410MS-120BK ELECTRIC STIMULATOR (EXTENSION UNIT)Nihon Kohden Corp.2011-08-04
K102802INTEGRA ELECTRODE TUNNELING NEEDLEIntegra LifeSciences Corporation2010-11-23
K082629S12X WITH ESAX OPTIONChatten Associates, Inc.2009-07-01
K082474PMT SUBDURAL CORTICAL ELECTRODESPmt Corp.2009-05-08