VS3-IR-MMS System— 510(k) K150018
Substantially EquivalentVisionsense, Ltd.
FDA 510(k) clearance K150018 for VS3-IR-MMS System, Substantially Equivalent on 2015-06-17. Applicant: Visionsense, Ltd.. Device class: 2.
Clearance details
- Applicant
- Visionsense, Ltd.
- Product code
- Code OWN
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Petach Tikva, Hamerkaz, IL
Recent devices under product code OWN
view allMore clearances from Visionsense, Ltd.
view allAdverse events under product code OWN
product code OWN- Malfunction
- 1,286
- Total
- 1,286
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K150018
K-number listed on FDA's recall record- Z-0280-2023 — VS3 Iridium Visionsense Infrared (IR) Fluorescence Miniature Microscope (MMS-IR) Product Number: 174-0012
- Z-0281-2023 — VS3 Iridium - Visionsense Infrared (IR) Fluorescence Miniature Microscope (MMS) - 785nm Product Number: 175-0012
- Z-0282-2023 — VS3 Iridium Visionsense Infrared (IR) Fluorescence Light Integrator (Beam Combiner) Product Number: 161-0001
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K150018.
Data sourced from openFDA. This site is unofficial and independent of the FDA.