510(k) K202925
K202925 is an FDA 510(k) premarket notification submitted by Karl Storz Endoscopy_America, Inc. for the device "KARL STORZ ICG Imaging System". The FDA issued a decision of Substantially Equivalent on Dec 17, 2020. The device falls under product code OWN (Confocal Optical Imaging), a Class II device regulated under 21 CFR 876.1500.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Dec 17, 2020
- Date Received
- Sep 29, 2020
- Clearance Type
- Traditional
- 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.