FDA.reportPublic FDA data

FLASH EVD System

Primary DI
00628341521352
Brand
FLASH EVD System
Company
7D Surgical ULC
Model
10-0002
Published
2026-04-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
K242480000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K242480000FLASH EVD System (10-0002)7D Surgical ULC2024-12-27HAW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00628341521352PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00628341521352006283415213526283415213520628341521352

GMDN Terms#

Term, Definition table
TermDefinition
Optical surgical navigation device tracking systemA mobile assembly of electrically-powered devices intended to provide a physician with optical tools to track manual surgical instruments and locate anatomical structures with respect to pre-acquired images (e.g., CT/MRI scan) or real-time data [e.g., endoscopic, ultrasound (US)]; it may be capable of creating digital 3-D patient models. It consists of a workstation with controls/display, position/movement tracking cameras (e.g., infrared), adaptors, and sensors/spatial markers designed to be attached to the patient and instruments. It is used for multiple surgical procedures (e.g., craniotomy, tumour resection) in various fields [e.g., ENT, neurosurgery, CMF surgery].

Regulatory Flags#

DUNS number
204326292
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00628341520775Short Drill Guide Sterilization Tray11-00912022-04-07
006283415208297D Surgical FLASH EVD Procedural Kit11-00722026-04-08
006283415208367D Surgical FLASH EVD Non-Sterile Kit11-00732026-04-08
006283415208437D Surgical FLASH EVD Sterile Kit11-00742026-04-08
006283415214067D Surgical Universal Tracking Sterilization Tray11-01432025-09-17
006283415213837D Surgical Universal Array (5)11-01412025-07-28
006283415213907D Surgical Universal Array (6)11-01422025-07-28
006283415209047D Surgical Iliac Cross Pin, 100 mm11-01012023-02-21
006283415209357D Surgical Iliac Cross Pin, 150 mm11-01042023-02-21
006283415201887D Surgical Steinmann Pin (ø3.2mm x 150mm) 11-00312021-07-27
006283415201957D Surgical Steinmann Pin (ø4.0mm x 150mm)11-00322021-07-27
006283415210557D Surgical Iliac Dual Pin Sterilization Tray11-01252024-07-19
006283415208507D Surgical Reference Clamp (Gator)11-00962023-01-12
006283415210247D Surgical Flex Rod Connector (4.5 mm - 100 mm)11-01132023-08-18
006283415208747D Surgical Spine Reference Clamp (Multi-Level)11-00982023-07-31
006283415207997D Surgical Pedicle Probe (Slim)11-00922022-09-21
006283415208057D Surgical Universal Array 311-00932022-09-21
006283415208127D Surgical Universal Array 411-00942022-09-21
006283415205777D Surgical Universal Clamp (Stryker Adapter)11-006711-00672020-11-18
006283415206907D Surgical Universal Clamp (SeaSpine Adapter)11-00792022-01-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00199150054466N/AMEDTRONIC NAVIGATION, INC.HAW2026-08-08
00763000381141N/AMEDTRONIC NAVIGATION, INC.HAW2026-08-08
00199150054398StealthStation S8MEDTRONIC NAVIGATION, INC.HAW2026-08-07
G076A900687A0Localite TMS Navigator TSLOCALITE GmbHHAW2026-08-03
04719878691024Nao Trac SBRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25
04719878691208Foot ControllerBRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25
04719878691246Display ScreenBRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25
04719878691307USB MouseBRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25
04719878691420Power Supply CordBRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25
04719878691468Power Supply Cord (US) 5mBRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25
04719878692021Surgical Equipment Drape PacksBRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25
04719878693004Reference StylusBRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25
04719878693042Tag SBRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25
04719878693127Tag Support ArmBRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25
04719878694001Instrument Registration Platform CoverBRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25
04719878695022Instrument Holder SBRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25
04719878695046Instrument Adaptor (3 mm)BRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25
04719878695060Instrument Adaptor (4 mm)BRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25
04719878695084Instrument Adaptor (5 mm)BRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25
04719878695107Instrument Adaptor (8 mm)BRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25
04719878695121SEEG AdaptorBRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25
04719878695145Catheter AdaptorBRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25
04719878695169Thumb Screw of Instrument HolderBRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25
04719878695183Set Screw of Instrument HolderBRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25
04719878695206Pin Screw of Instrument AdaptorBRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25
04719878695220Catheter Adaptor_3.5mmBRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25
04719878695244Instrument Adaptor (1.8 mm)BRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25
04719878695268Instrument Adaptor (2 mm)BRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25
04719878695282Instrument Adaptor (2.2 mm)BRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25
04719878695305Instrument Adaptor (2.5 mm)BRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25