Company ยท US
Visionsense, Ltd.
FDA 510(k) clearances and medical device recalls filed under this name, 2008 to 2022. Name variants (Inc, Corp, punctuation) are merged.
13510(k) clearances (0 in 12 months)
4recalls (0 in 12 months)
4recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 28, 2022 | K223020 | VS3-Iridium System (VS3-IR) Visionsense, Ltd., IL | OWN |
| Nov 22, 2021 | K210265 | VS3 Iridium Sytem Visionsense, Ltd., IL | OWN |
| Feb 5, 2018 | K171208 | Trans-anal Introducer Visionsense, Ltd., IL | FED |
| Feb 22, 2016 | K153548 | VS3 STEREOSCOPIC HIGH DEFINITION VISION SYSTEM Visionsense, Ltd., IL | HRX |
| Oct 28, 2015 | K152204 | VS3-IR system Visionsense, Ltd., IL | OWN |
| Jun 17, 2015 | K150018 | VS3-IR-MMS System Visionsense, Ltd., IL | OWN |
| Jun 26, 2014 | K141002 | VS3 STEREOSCOPIC HIGH DEFINITION VISION SYSTEM Visionsense, Ltd. | HRX |
| Jul 16, 2013 | K131434 | VS3 STEREOSCOPIC HIGH DEFINITION VISION SYSTEM Visionsense, Ltd. | GWG |
| Apr 17, 2013 | K123467 | VS3 Visionsense, Ltd. | GCJ |
| Dec 15, 2008 | K082355 | VISIONSENSE STEREOSCOPIC VISION SYSTEM Visionsense, Ltd. | HRX |
| Oct 30, 2008 | K082667 | VISIONSENSE STEREOSCOPIC VISION SYSTEM (VS SYSTEM) Visionsense, Ltd. | EOB |
| May 29, 2008 | K081102 | VSU - VISIONSENSE STEREOSCOPIC VISION SYSTEM Visionsense, Ltd. | GWG |
| Mar 5, 2008 | K073279 | VS-VISIONSENSE STEREOSCOPIC VISION SYSTEM Visionsense, Ltd. | GCJ |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 23, 2022 | Visionsense, Ltd. VS3 Iridium Visionsense Infrared (IR) Fluorescence Light Integrator (Beam Combiner)
Product Number: 161-0001 Open, Classified |
OWN | K150018 |
| Nov 23, 2022 | Visionsense, Ltd. VS3 Iridium - Visionsense Infrared (IR) Fluorescence Miniature Microscope (MMS) - 785nm
Product Number: 175-0012 Open, Classified |
OWN | K150018 |
| Nov 23, 2022 | Visionsense, Ltd. VS3 Iridium Visionsense Infrared (IR) Fluorescence Miniature Microscope (MMS-IR)
Product Number: 174-0012 Open, Classified |
OWN | K150018 |
| Mar 8, 2012 | Visionsense, Ltd. 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, Terminated |
GWG | K081102 |