FDA.reportPublic FDA data

ClearPoint Neuro Inc.

Matched from indexed company URL: Clearpoint-Neuro-Inc

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30280064583028006458ClearPoint Neuro Inc.1N2026-01-016349 Paseo Del Lago Carlsbad CA US 92011
11257323002838670ClearPoint Neuro Inc.1N2020-04-255 Musick Irvine CA US 92618

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3206271748439818K961113CNS INTERCHANGEABLE BIT CRANIAL DRILLHBG1996-06-05
3206271145355214K243657ClearPoint System (Software Version 3.0)HAW2025-01-24
3206271617133344K233703Bone Anchor (NGS-BA-01)HAW2024-04-26
3206271829447337K233155ClearPointer Optical Navigation WandHAW2024-01-12
3206271284638204K233144ClearPoint Bone Screw FiducialsHAW2024-01-12
3206271518911238K233141SmartFrame ORHAW2024-01-12
3206271234520034K232102ClearPoint Array System (Version 1.2)HAW2023-09-15
3206272042833514K231664IRRAflow Active Fluid Exchange System (AFES)JXG2023-10-19
3206271696755265K213645ClearPoint Maestro Brain ModelQIH2022-08-08
3206271690255176K200079ClearPoint System and AccessoriesHAW2020-02-13
3206271091521863K191701Arcus Head Fixation FrameHBL2019-11-15
773111091521863K191701Arcus Head Fixation FrameHBL2019-11-15
773111790993726K191400Voyager Trajectory Array Guide (V-TAG)HAW2019-06-21
773111863218312K181731MR Compatible Aspiration KitGWG2018-11-20
3206271863218312K181731MR Compatible Aspiration KitGWG2018-11-20
773111616296006K181195ClearPoint SystemORR2018-11-02
773111853395261K180854Voyager Trajectory Array Guide (V-TAG)HAW2018-07-23
3206271934136221K171880IRRAflow CNS SystemJXG2018-07-13
773111925207998K171257ClearPoint SystemORR2017-10-20
3206272036485168K161010HICP200 Patient/Monitor Interconnect CableGWM2016-10-20
773111627832524K160434ClearPoint SystemHAW2016-03-17
3206271288347578K160129MRII Cranial Drill and AccessoriesHBG2016-03-26
773111288347578K160129MRII Cranial Drill and AccessoriesHBG2016-03-26
773111548636296K151536SmartTwist MRII Hand Drill, SmartTip MRII Drill bit Kit, 4.5mm, 6.0mmHBG2015-07-08
773111199096262K142505ClearPoint SystemHAW2015-10-21
3206271620424860K132436VARIOGUIDE DRILL KITHBE2014-03-20
773111801343784K122456MRII CRAINIAL DRILLHBG2013-03-22
773111972940583K111802SV BRAIN ARRAY, SIEMENS 3TMOS2011-09-08
3206271972940583K111802SV BRAIN ARRAY, SIEMENS 3TMOS2011-09-08
773111168753638K111259SV DBS VRAIN ARRAYMOS2011-07-05
773111900994005K111073SURGIVISION INC. CLEARPOINT SYSTEMORR2011-06-22
3206271691983942K102101SURGIVISION MR COMPATIBLE VENTRICULAR CANNULAHCD2011-01-26
773111691983942K102101SURGIVISION MR COMPATIBLE VENTRICULAR CANNULAHCD2011-01-26
773111675561993K100836CLEARPOINT SYSTEMORR2010-06-16
773111411890043K091439HEAD FIXATION ARC AND TABLE BASEHBL2009-08-25
3206271411890043K091439HEAD FIXATION ARC AND TABLE BASEHBL2009-08-25
3206271821632339K091343MRI NEURO DRAPEKKX2009-09-22
773111821632339K091343MRI NEURO DRAPEKKX2009-09-22
3206271977007023K090267SV DBS BRAIN ARRAY, MODEL 1500SV-SMS64MOS2009-03-16
773111977007023K090267SV DBS BRAIN ARRAY, MODEL 1500SV-SMS64MOS2009-03-16
3206271834481702K083378SYNERGYGWM2009-09-29
3206271333552441DEN240023SmartFlow Neuro CannulaSDG2024-11-13
3206271487422574
3206271499125585
3206271573354889
3206271924239519
3206271977071916

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
HAW112025-01-24
HBG52016-03-26
MOS52011-09-08
HBL42019-11-15
ORR42018-11-02
GWM32016-10-20
JXG22023-10-19
GWG22018-11-20
HCD22011-01-26
KKX22009-09-22
SDG12024-11-13
QIH12022-08-08
HBE12014-03-20