510(k) K151243
K151243 is an FDA 510(k) premarket notification submitted by Stryker Endoscopy for the device "STRYKER INFRARED ILLUMINATION SYSTEM (IRIS) [AIM Light Source and IRIS Ureteral Kit]". The FDA issued a decision of Substantially Equivalent on August 20, 2015. The device falls under product code FCS (Light, Catheter, Fiberoptic, Glass, Ureteral), a Class II device regulated under 21 CFR 876.4020. Stryker Endoscopy has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 20, 2015
- Date Received
- May 11, 2015
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Light, Catheter, Fiberoptic, Glass, Ureteral
- Device Class
- Class II
- Regulation Number
- 876.4020
- Review Panel
- GU
- Submission Type