FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VSU - VISIONSENSE STEREOSCOPIC VISION SYSTEM
K Number: K081102
·
Decision May 29, 2008
Classifications
1
FEI Numbers
65
Registration Numbers
65
Same Product Code
92
Applicant Total
13
Review Days
42
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- VSU - VISIONSENSE STEREOSCOPIC VISION SYSTEM
- K Number
- K081102
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.1480
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Visionsense, Ltd.
- Date Received
- April 17, 2008
- Decision Date
- May 29, 2008
- Product Code
- GWG
- Advisory Committee
- Neurology
- Review Advisory Committee
- NE
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| GWG | Endoscope, Neurological | FDA class 2 | Neurology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GWG), ordered by most recent decision date.
Precision S 4K Sinuscope
FDA 510(k)
FDA Class 2
·Neurology
Hydro Irrigation System
FDA 510(k)
FDA Class 2
·Neurology
HJY VisualNext 3D Endoscopic Vision System
FDA 510(k)
FDA Class 2
·Neurology
AURORA® Surgiscope® System (ASX15/60); AURORA® Surgiscope® System (ASX15/80)
FDA 510(k)
FDA Class 2
·Neurology
cCeLL - In vivo
FDA 510(k)
FDA Class 2
·Neurology
Digital ClarusScope System, Digital NeuroPEN System
FDA 510(k)
FDA Class 2
·Neurology
Other Clearances by Visionsense, Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K223020 | VS3-Iridium System (VS3-IR) | Oct 28, 2022 | Substantially Equivalent |
| K210265 | VS3 Iridium Sytem | Nov 22, 2021 | Substantially Equivalent |
| K171208 | Trans-anal Introducer | Feb 5, 2018 | Substantially Equivalent |
| K153548 | VS3 STEREOSCOPIC HIGH DEFINITION VISION SYSTEM | Feb 22, 2016 | Substantially Equivalent |
| K152204 | VS3-IR system | Oct 28, 2015 | Substantially Equivalent |
| K150018 | VS3-IR-MMS System | Jun 17, 2015 | Substantially Equivalent |
| K141002 | VS3 STEREOSCOPIC HIGH DEFINITION VISION SYSTEM | Jun 26, 2014 | Substantially Equivalent |
| K131434 | VS3 STEREOSCOPIC HIGH DEFINITION VISION SYSTEM | Jul 16, 2013 | Substantially Equivalent |
| K123467 | VS3 | Apr 17, 2013 | Substantially Equivalent |
| K082355 | VISIONSENSE STEREOSCOPIC VISION SYSTEM | Dec 15, 2008 | Substantially Equivalent |