SmartSurgN Visualization System— 510(k) K242163
Substantially EquivalentSmartsurgN, Inc.
FDA 510(k) clearance K242163 for SmartSurgN Visualization System, Substantially Equivalent on 2026-04-20. Applicant: SmartsurgN, Inc.. Device class: 2.
Summary
SmartsurgN's SmartSurgN Visualization System is filed under product code OWN (Confocal Optical Imaging). The record doesn't describe the system beyond its name and that code name.
Class II, 21 CFR 876.1500. The General and Plastic Surgery review panel handled it as a Traditional 510(k), though the record lists Gastroenterology and Urology as the classification panel.
SmartsurgN filed from San Jose, California. The decision came 635 calendar days after FDA received it (July 24, 2024 to April 20, 2026).
Clearance details
- Applicant
- SmartsurgN, Inc.
- Product code
- Product code OWN
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Jose, CA, US
Recent devices under product code OWN
view allMore clearances from SmartsurgN, Inc.
view allAdverse events under product code OWN
product code OWN- Malfunction
- 1,286
- Total
- 1,286
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.