ENDOCLEAR SYSTEM— 510(k) K100346
Substantially EquivalentVirtual Ports, Ltd.
FDA 510(k) clearance K100346 for ENDOCLEAR SYSTEM, Substantially Equivalent on 2010-03-10. Applicant: Virtual Ports, Ltd.. Device class: 2.
Clearance details
- Applicant
- Virtual Ports, 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
- Binyamina, IL
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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 Virtual Ports, 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.