Clearance Summary
SPY Portable Handheld Imaging (SPY-PHI) System received FDA 510(k) clearance under submission number K190729, sponsored by Novadaq Technologies Ulc. (Now A Part of Stryker). The device was reviewed via the Special premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 2019-04-19.
- Submission: K190729
- Applicant / Sponsor: Novadaq Technologies Ulc. (Now A Part of Stryker)
- Clearance pathway: Special
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1500
- Decision date: 2019-04-19
Classification & Regulation
This clearance is catalogued under FDA product code OWN and 21 CFR 876.1500, within the Gastroenterology, Urology review panel as a Class II device.