Synaptive Medical Inc
Mississauga Ontario, CA
Synaptive Medical Inc appears in FDA device records in Mississauga Ontario, CA. FDA records list 10 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 5 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 10 510(k) clearances for Synaptive Medical Inc between 2014 and 2024. The busiest year on record is 2016, with 3. The most recent is 2024, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2014 | 1 |
| 2015 | 1 |
| 2016 | 3 |
| 2018 | 1 |
| 2019 | 1 |
| 2020 | 1 |
| 2023 | 1 |
| 2024 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K231986 | Modus IR | IZI | Substantially Equivalent | |
| K232981 | Synq Software Version 1.3 | LNH | Substantially Equivalent | |
| K200327 | Evry | LNH | Substantially Equivalent | |
| K183325 | Modus Nav | HAW | Substantially Equivalent | |
| K180394 | BrightMatter Plan 1.6.0 | LLZ | Substantially Equivalent | |
| K160523 | BrightMatter Guide with BrightMatter Pointer | HAW | Substantially Equivalent | |
| K153281 | BrightMatter Guide with Surface Trace Registration | HAW | Substantially Equivalent | |
| K153284 | Synaptive ImageDrive Pro | LLZ | Substantially Equivalent | |
| K142024 | BRIGHTMATTER NAVIGATION SYSTEM | HAW | Substantially Equivalent | |
| K140337 | BRIGHTMATTER PLANNING SOFTWARE | LLZ | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3012075008 | 3012075008 | Synaptive Medical Inc | 5055 Satellite Drive, Mississauga Ontario L4W 5K7 CA | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1955-2021 | Synaptive Trackable Suction Set Standard and Malleable | Due to visible burrs/metal filings affixed along the suction tube inner perimeter. | Class II | Terminated | |
| Z-1759-2020 | Synaptive ImageDrive Clinical | A software defect negatively affects the quality of images taken during diagnostic imaging (mammograms) which may result in misdiagnosis. | Class II | Terminated | |
| Z-1758-2020 | ClearCanvas RIS/PACS | A software defect negatively affects the quality of images taken during diagnostic imaging (mammograms) which may result in misdiagnosis. | Class II | Terminated | |
| Z-0470-2019 | 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 the port directly. As the BrainPath is navigable in two configurations (sheath only / sheath and obturator), the tip of the obturator is represented in the software with a tip extension beyond the bottom of the sheath. Note sheath and cannula are used interchangeably in this document. | 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. | Class I | Terminated | |
| Z-0480-2016 | 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 guidance system to enable open and percutaneous computer assisted surgery. The system is indicated for medical conditions requiring neurosurgical cranial procedures. It can be used for intra-operative guidance where a reference to a rigid anatomical structure can be identified. | 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. | Class II | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain