FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VS3 STEREOSCOPIC HIGH DEFINITION VISION SYSTEM
K Number: K131434
·
Decision Jul 16, 2013
Classifications
1
FEI Numbers
65
Registration Numbers
65
Same Product Code
92
Applicant Total
13
Review Days
60
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Basic Information
- Device Name
- VS3 STEREOSCOPIC HIGH DEFINITION VISION SYSTEM
- K Number
- K131434
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 882.1480
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Visionsense, Ltd.
- Date Received
- May 17, 2013
- Decision Date
- July 16, 2013
- 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 |
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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 |
| K123467 | VS3 | Apr 17, 2013 | Substantially Equivalent |
| K082355 | VISIONSENSE STEREOSCOPIC VISION SYSTEM | Dec 15, 2008 | Substantially Equivalent |
| K082667 | VISIONSENSE STEREOSCOPIC VISION SYSTEM (VS SYSTEM) | Oct 30, 2008 | Substantially Equivalent |