K242163
- 510(k) number
- K242163
- Device name
- SmartSurgN Visualization System
- Applicant
- SmartsurgN, Inc. CA · US
- Product code
- OWN — Confocal Optical Imaging
- Decision date
- 2026-04-20
- Date received
- 2024-07-24
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
510(k) Summary (official FDA PDF): K242163.pdf
Official FDA record: K242163
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.