Visionsense, Ltd.
Washington, DC, US
Visionsense, Ltd. appears in FDA device records in Washington, DC. FDA records list 13 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show 4 recalls for this company.
FDA records held for this company
510(k) clearance history
FDA records hold 13 510(k) clearances for Visionsense, Ltd. between 2008 and 2022. The busiest year on record is 2008, with 4. The most recent is 2022, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2008 | 4 |
| 2013 | 2 |
| 2014 | 1 |
| 2015 | 2 |
| 2016 | 1 |
| 2018 | 1 |
| 2021 | 1 |
| 2022 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K223020 | VS3-Iridium System (VS3-IR) | OWN | Substantially Equivalent | |
| K210265 | VS3 Iridium Sytem | OWN | Substantially Equivalent | |
| K171208 | Trans-anal Introducer | FED | Substantially Equivalent | |
| K153548 | VS3 STEREOSCOPIC HIGH DEFINITION VISION SYSTEM | HRX | Substantially Equivalent | |
| K152204 | VS3-IR system | OWN | Substantially Equivalent | |
| K150018 | VS3-IR-MMS System | OWN | Substantially Equivalent | |
| K141002 | VS3 STEREOSCOPIC HIGH DEFINITION VISION SYSTEM | HRX | Substantially Equivalent | |
| K131434 | VS3 STEREOSCOPIC HIGH DEFINITION VISION SYSTEM | GWG | Substantially Equivalent | |
| K123467 | VS3 | GCJ | Substantially Equivalent | |
| K082355 | VISIONSENSE STEREOSCOPIC VISION SYSTEM | HRX | Substantially Equivalent | |
| K082667 | VISIONSENSE STEREOSCOPIC VISION SYSTEM (VS SYSTEM) | EOB | Substantially Equivalent | |
| K081102 | VSU - VISIONSENSE STEREOSCOPIC VISION SYSTEM | GWG | Substantially Equivalent | |
| K073279 | VS-VISIONSENSE STEREOSCOPIC VISION SYSTEM | GCJ | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0282-2023 | VS3 Iridium Visionsense Infrared (IR) Fluorescence Light Integrator (Beam Combiner) Product Number: 161-0001 | Broken Optical fiber cable damage can occur through handling or bending and can lead to loss of functionality and heating/melting of the outer cable surface. | Class II | Open, Classified | |
| Z-0281-2023 | VS3 Iridium - Visionsense Infrared (IR) Fluorescence Miniature Microscope (MMS) - 785nm Product Number: 175-0012 | XXX | Class II | Open, Classified | |
| Z-0280-2023 | VS3 Iridium Visionsense Infrared (IR) Fluorescence Miniature Microscope (MMS-IR) Product Number: 174-0012 | Broken Optical fiber cable damage can occur through handling or bending and can lead to loss of functionality and heating/melting of the outer cable surface. | Class II | Open, Classified | |
| Z-1192-2012 | Visionsense Stereoscopic Vision System, Brand name VSII, Model/Part Numbers 172-0030 and 172-0040 --- Classification Name: Neurological Endoscope --- NOTE: Model Numbers 172-0032, 172-0044, 172-0070, 172-0072, 172-0080 were also included in the firm's recall action but these never entered US commerce. These were distributed directly from Israel to the foreign consignees. --- The VSII is intended for viewing internal surgical sites during general surgical procedures and for use in visualization of ventricles and structures within the brain during neurological surgical procedures. These devices do not carry an expiration date. However, they are automatically taken out of service and replaced after 40 uses. | A complaint was received and a unit returned that exhibited the metal and glass shaft window becoming dislodged during scope cleaning. Additionally, during in-process visual inspection of the metal and glass shaft window sub-assembly from a specific batch that was received from the supplier it was noted that the window at the tip of the scope was not seated properly. It was determined that the wi | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain