Canady Flex RoboWrist— 510(k) K212736
Substantially EquivalentUs Medical Innovations, LLC
FDA 510(k) clearance K212736 for Canady Flex RoboWrist, Substantially Equivalent on 2022-11-22. Applicant: Us Medical Innovations, LLC. Device class: 2.
Clearance details
- Applicant
- Us Medical Innovations, LLC
- 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
- Traditional
- Location
- Takoma Park, MD, 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 Us Medical Innovations, LLC
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.