FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VS-VISIONSENSE STEREOSCOPIC VISION SYSTEM
K Number: K073279
·
Decision Mar 5, 2008
Classifications
1
FEI Numbers
548
Registration Numbers
548
Same Product Code
1422
Applicant Total
13
Review Days
105
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
- VS-VISIONSENSE STEREOSCOPIC VISION SYSTEM
- K Number
- K073279
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Visionsense, Ltd.
- Date Received
- November 21, 2007
- Decision Date
- March 5, 2008
- Product Code
- GCJ
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| GCJ | Laparoscope, General & Plastic Surgery | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GCJ), ordered by most recent decision date.
FloShield Air System (FSS-01-1000T - 10mm, 0 Degree FloShield Air, FSS-02-1030T - 10mm, 30 Degree FloShield Air, FSS-03-1045T - 10mm, 45 Degree FloShield Air, FSS-01-0500T - 5mm, 0 Degree FloShield Air, FSS-02-0530T - 5mm, 30 Degree FloShield Air, FSS-01-0545T - 5mm, 45 Degree FloShield Air)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Tech-Image Video Endoscope System
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
TroKit Laparoscope Lens Wiper
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Inno-Port Disposable Bladed Trocar
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
4K NIR/ICG Imaging System
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
MediBot Needle Driver Uno
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
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 |