VS3— 510(k) K123467
Substantially EquivalentVisionsense, Ltd.
FDA 510(k) clearance K123467 for VS3, Substantially Equivalent on 2013-04-17. Applicant: Visionsense, Ltd.. Device class: 2.
Clearance details
- Applicant
- Visionsense, Ltd.
- Product code
- Code GCJ
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Washington, DC, US
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- K253541 — EZ-Close (EZ Close Port Site Closing Device, EZ Close MAX Port Site Closing Device, EZ Close II Port Site Closing Device)
More clearances from Visionsense, Ltd.
view allAdverse events under product code GCJ
product code GCJ- Death
- 39
- Injury
- 1,638
- Malfunction
- 28,216
- Other
- 11
- Total
- 29,904
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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.