510(k) K253972
K253972 is an FDA 510(k) premarket notification submitted by Karl Storz SE & CO. KG for the device "IMAGE1 (TC400US); X-to-4U Adapter (TC040)". The FDA issued a decision of Substantially Equivalent on February 12, 2026. The device falls under product code OWN (Confocal Optical Imaging), a Class II device regulated under 21 CFR 876.1500. Karl Storz SE & CO. KG has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 12, 2026
- Date Received
- December 11, 2025
- 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
Collection of light signals for visualization of cellular microstructures.