Clearance Summary
STRYKER INFRARED ILLUMINATION SYSTEM (IRIS) [AIM Light Source and IRIS Ureteral Kit] received FDA 510(k) clearance under submission number K151243, sponsored by Stryker Endoscopy. 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 2015-08-20.
- Submission: K151243
- Applicant / Sponsor: Stryker Endoscopy
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.4020
- Decision date: 2015-08-20
Classification & Regulation
This clearance is catalogued under FDA product code FCS and 21 CFR 876.4020, within the Gastroenterology, Urology review panel as a Class II device.