SPY-PHI System with SPY-PHI Fluorescence Assessment Software— 510(k) K202244
Substantially EquivalentNovadaq Technologies Ulc. (Now A Part of Stryker)
FDA 510(k) clearance K202244 for SPY-PHI System with SPY-PHI Fluorescence Assessment Software, Substantially Equivalent on 2020-11-05. Applicant: Novadaq Technologies Ulc. (Now A Part of Stryker).
Clearance details
- Applicant
- Novadaq Technologies Ulc. (Now A Part of Stryker)
- Product code
- Code OWN
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Burnaby, CA
Adverse events under product code OWN
product code OWN- Malfunction
- 1,286
- Total
- 1,286
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.