Clearance Summary
PINPOINT Endoscopic Fluorescence Imaging System received FDA 510(k) clearance under submission number K182606, sponsored by Novadaq Technologies Ulc. (Now A Part of Stryker). The device was reviewed via the Traditional premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 2018-11-21.
- Submission: K182606
- Applicant / Sponsor: Novadaq Technologies Ulc. (Now A Part of Stryker)
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1500
- Decision date: 2018-11-21
Classification & Regulation
This clearance is catalogued under FDA product code GCJ and 21 CFR 876.1500, within the Gastroenterology, Urology review panel as a Class II device.