780 nm SPY Portable Handheld Imaging (SPY-PHI) System— 510(k) K261037
Substantially EquivalentStryker Endoscopy
FDA 510(k) clearance K261037 for 780 nm SPY Portable Handheld Imaging (SPY-PHI) System, Substantially Equivalent on 2026-05-28. Applicant: Stryker Endoscopy. Device class: 2.
Summary
Stryker Endoscopy's 780 nm SPY Portable Handheld Imaging (SPY-PHI) System is filed under IZI, angiographic x-ray systems.
Class II, 21 CFR 892.1600. The General and Plastic Surgery review panel handled it as a Traditional 510(k), though the record lists Radiology as the classification panel.
Stryker filed from San Jose, California. Review took 59 calendar days (March 30 to May 28, 2026).
Clearance details
- Applicant
- Stryker Endoscopy
- Product code
- Product code IZI
- Device class
- Class 2
- Regulation
- 21 CFR 892.1600
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Jose, CA, US
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Adverse events under product code IZI
product code IZI- Death
- 9
- Malfunction
- 5,312
- Total
- 5,321
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.