Data / Medical devices / Canada / Synaptive Medical Inc

Synaptive Medical Inc: FDA-registered device maker in Mississauga Ontario, Canada, 11 510(k) clearances

Name: Synaptive Medical Inc FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Synaptive Medical Inc is registered with the FDA (registration 3012075008) in Mississauga Ontario, Canada. It lists 7 device types. The FDA files 11 510(k) clearances under its listings, the newest dated March 25, 2024. 4 recall events name it as the recalling firm (1 Class I). Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3012075008
Address: 5055 Satellite Drive Unit #1, Mississauga Ontario, Canada, L4W 5K7
Owner or operator: Synaptive Medical Inc (10046804)
Roles: Exporter to the US, Manufacturer
First device listed: June 10, 2014
Registered through: 2026
Brand names listed: 55 Sony Display, BrightMatter Guide, BrightMatter Navigation System, BrightMatter Planning Software, Evry, ImageDrive Clinical, Modus Blue, Modus IR and more

Devices it lists

Device	Product code	Class	Role	Source
Apparatus, Suction, Operating-Room, Wall Vacuum Powered	GCX	2	Manufacturer	accessdata.fda.gov
Camera, Surgical And Accessories	KQM	1	Exporter to the US	accessdata.fda.gov
Microscope, Surgical	EPT	1	Manufacturer	accessdata.fda.gov
Neurological Stereotaxic Instrument	HAW	2	Exporter to the US, Manufacturer	accessdata.fda.gov
System, Image Processing, Radiological	LLZ	2	Manufacturer	accessdata.fda.gov
System, Nuclear Magnetic Resonance Imaging	LNH	2	Manufacturer	accessdata.fda.gov
System, X-Ray, Angiographic	IZI	2	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
March 25, 2024	K231986	Modus IR	IZI	Substantially Equivalent	Synaptive Medical, Inc.	accessdata.fda.gov
October 11, 2023	K232981	Synq Software Version 1.3	LNH	Substantially Equivalent	Synaptive Medical, Inc.	accessdata.fda.gov
April 29, 2020	K200327	Evry	LNH	Substantially Equivalent	Synaptive Medical, Inc.	accessdata.fda.gov
July 14, 2019	K183325	Modus Nav	HAW	Substantially Equivalent	Synaptive Medical, Inc.	accessdata.fda.gov
March 9, 2018	K180394	BrightMatter Plan 1.6.0	LLZ	Substantially Equivalent	Synaptive Medical, Inc.	accessdata.fda.gov
June 24, 2016	K160523	BrightMatter Guide with BrightMatter Pointer	HAW	Substantially Equivalent	Synaptive Medical, Inc.	accessdata.fda.gov
March 30, 2016	K153281	BrightMatter Guide with Surface Trace Registration	HAW	Substantially Equivalent	Synaptive Medical, Inc.	accessdata.fda.gov
March 29, 2016	K153284	Synaptive ImageDrive Pro	LLZ	Substantially Equivalent	Synaptive Medical, Inc.	accessdata.fda.gov
April 2, 2015	K142024	BRIGHTMATTER NAVIGATION SYSTEM	HAW	Substantially Equivalent	Synaptive Medical, Inc.	accessdata.fda.gov
June 2, 2014	K140337	BRIGHTMATTER PLANNING SOFTWARE	LLZ	Substantially Equivalent	Synaptive Medical, Inc.	accessdata.fda.gov
January 27, 2004	K033621	NDI PASSIVE SPHERES	HAW	Substantially Equivalent	Northern Digital, Inc.	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
April 23, 2021	87937	Class II	Terminated	Synaptive Trackable Suction Set Standard and Malleable	Due to visible burrs/metal filings affixed along the suction tube inner perimeter.	accessdata.fda.gov
February 26, 2020	85216	Class II	Terminated	ClearCanvas RIS/PACS	A software defect negatively affects the quality of images taken during diagnostic imaging (mammograms) which may result in misdiagnosis.	accessdata.fda.gov
October 9, 2018	81317	Class I	Terminated	BrightMatter Guide, Product Number SYN-0026, Versions: 1.5.0, 1.5.1 and 1.5.2 Product Usage: BrightMatter Guide can navigate a third-party port (NICO BrainPath device) by attaching Synaptive s custom Tracking Array to th	This recall has been initiated due to a software defect found in the Guide System software when used with NICO BrainPath ports under certain circumstances. When one trajectory is set with a blue port and another trajectory is set with a gold port, the software defect is triggered when the user switches between these trajectories during a surgical procedure.	accessdata.fda.gov
December 4, 2015	72747	Class II	Terminated	Synaptive Medical BrightMatter Navigator System (Guide System). Part number SYN-0026. The Guide system is comprised of a cart labelled SYN-0024 and a cart labelled SYN-0025, Operator Cart. A planning and intraoperative g	Out of tolerance for radio frequency emissions. At the 150-1000MHz frequency, the testing indicated the BrightMatter Navigation system was up to 20dB uV/meter higher than the applicable IEC 60601-1-2:2007 (Ed3.0) standard specification.	accessdata.fda.gov

Compare with other makers

Updated March 25, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.