ZeroWire Duo Wireless HD Video Transfer System G2 or ZeroWire G2— 510(k) K151609
Substantially EquivalentNds Surgical Imaging, LLC
FDA 510(k) clearance K151609 for ZeroWire Duo Wireless HD Video Transfer System G2 or ZeroWire G2, Substantially Equivalent on 2015-11-06. Applicant: Nds Surgical Imaging, LLC.
Clearance details
- Applicant
- Nds Surgical Imaging, LLC
- Product code
- Code GCJ
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Jose, CA, US
Adverse 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.