510(k) K173866
K173866 is an FDA 510(k) premarket notification submitted by Stryker for the device "Stryker AIM Light Source and SafeLight cable". The FDA issued a decision of Substantially Equivalent on Jan 18, 2018. The device falls under product code OWN (Confocal Optical Imaging), a Class II device regulated under 21 CFR 876.1500. Stryker has 270 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jan 18, 2018
- Date Received
- Dec 20, 2017
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Confocal Optical Imaging
- Device Class
- Class II
- Regulation Number
- 876.1500
- Review Panel
- SU
- Submission Type
- 510(k)
Collection of light signals for visualization of cellular microstructures.