FDA.reportPublic FDA data

ClearPoint

Primary DI
00850047354136
Brand
ClearPoint
Company
Clearpoint Neuro, Inc.
Model
CP-WRK-WIN11
Catalog number
CP-WRK-WIN11
Device description
ClearPoint Neuro Workstation - Win 11
Published
2025-02-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HAWNeurological Stereotaxic Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HAWNeurological Stereotaxic InstrumentNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K243657000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K243657000ClearPoint System (Software Version 3.0)ClearPoint Neuro, Inc.2025-01-24HAW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850047354136PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850047354136008500473541368500473541360850047354136

GMDN Terms#

Term, Definition table
TermDefinition
Neurological stereotactic surgery systemAn assembly of devices that typically consists of a rigid frame, positioning and alignment components, workstation, and a calibrated guide mechanism for precisely positioning probes, other instruments, or implantable devices during neurosurgery. The system may include computerized functions to store diagnostic images used for image-guided surgery.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
949-900-6833quality@clearpointneuro.com

Regulatory Flags#

DUNS number
119078557
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850013266012Hummingbird® Patient MonitorHICP200HICP2002019-10-14
00850013266029Hummingbird® SynergyDuoH610H6102019-10-10
00850013266036Hummingbird® Parenchymal CatheterH110H1102019-10-10
00850013266180Hummingbird® Cranial Access Kit IC42-DIC42-D2020-01-29
00850013266197Hummingbird® Cranial Access KitIC42IC422020-01-29
00850013266203IRRAflow Tube SetICDS 030ICDS 0302023-11-02
00850013266234HummingbirdCK 402023-10-13
00850013266241HummingbirdCK 422023-10-13
00850013266272IRRAflow Cranial Access BoltICB 0102025-07-24
00868643000401IRRAflow®ICCU 020ICCU 0202019-01-22
00868643000463IRRAflow Laser Leveler PackageICLS 010ICLS 0102024-06-10
00868643000470IRRAflow Drainage Collection SystemDCS 010DCS 0102019-09-30
00868643000487Hummingbird® Cranial Access KitIC40DIC40-D2019-10-10
00868643000494Hummingbird® Cranial Access KitIC40IC402019-10-10
00850013266258IRRAflow Catheter 2.0+ICAT 0302025-05-07
00850013266005Hummingbird Cranial Access KitIC40IC402023-12-08
00850013266227Hummingbird Cranial Access KitIC422023-12-08
00850013266104Hummingbird® HICP200 Monitor Interconnect Cable - Spacelabs 6 Pin Monitor700033270003322020-05-28
00868643000418IRRAflow® Cassette and Tube SetICDS 020ICDS 0202019-01-22
00868643000425IRRAflow® 1.5 CatheterICGS 010ICGS 0102019-01-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06974813832681NASinovation (Beijing) Medical Technology Co., LtdHAW2026-09-29
06974813832698NASinovation (Beijing) Medical Technology Co., LtdHAW2026-09-29
06974813832704NASinovation (Beijing) Medical Technology Co., LtdHAW2026-09-29
06974813832711NASinovation (Beijing) Medical Technology Co., LtdHAW2026-09-29
06974813832728NASinovation (Beijing) Medical Technology Co., LtdHAW2026-09-29
06974813832735NASinovation (Beijing) Medical Technology Co., LtdHAW2026-09-29
06974813832742NASinovation (Beijing) Medical Technology Co., LtdHAW2026-09-29
06974813832759NASinovation (Beijing) Medical Technology Co., LtdHAW2026-09-29
06974813832766NASinovation (Beijing) Medical Technology Co., LtdHAW2026-09-29
06974813832773NASinovation (Beijing) Medical Technology Co., LtdHAW2026-09-29
06974813832780NASinovation (Beijing) Medical Technology Co., LtdHAW2026-09-29
06974813832797NASinovation (Beijing) Medical Technology Co., LtdHAW2026-09-29
06974813832810NASinovation (Beijing) Medical Technology Co., LtdHAW2026-09-29
06974813832827NASinovation (Beijing) Medical Technology Co., LtdHAW2026-09-29
06974813832834NASinovation (Beijing) Medical Technology Co., LtdHAW2026-09-29
06974813832841NASinovation (Beijing) Medical Technology Co., LtdHAW2026-09-29
00889024713895ROSA ONE BRAIN APPLICATION (US)MEDTECHHAW2026-09-28
00889024714113PLANNING STATION - USAMEDTECHHAW2026-09-28
00199150071968Stealth AXiS Leica KitMEDTRONIC NAVIGATION, INC.HAW2026-09-25
00199150071975Stealth AXiS Kinevo 900 KitMEDTRONIC NAVIGATION, INC.HAW2026-09-25
00199150071982Stealth AXiS Pentero 900 KitMEDTRONIC NAVIGATION, INC.HAW2026-09-25
00850088866001CBYONMED-SURGICAL SERVICES, INC.HAW2026-09-25
00199150054404ZEISS TIVATO 700MEDTRONIC NAVIGATION, INC.HAW2026-09-21
00199150054442ZEISS PENTERO 800SMEDTRONIC NAVIGATION, INC.HAW2026-09-21
07340201503683Leksell Vantage Stereotactic SystemElekta Solutions ABHAW2026-08-18
07340201503713Leksell Vantage Stereotactic SystemElekta Solutions ABHAW2026-08-18
07340201503720Leksell Vantage Stereotactic SystemElekta Solutions ABHAW2026-08-18
07340201503744Leksell Vantage Stereotactic SystemElekta Solutions ABHAW2026-08-18
07340201503768Leksell Vantage Stereotactic SystemElekta Solutions ABHAW2026-08-18
07340201503942Leksell Vantage Stereotactic SystemElekta Solutions ABHAW2026-08-18