SmartSurgN Visualization System— 510(k) K213943

Name: FDA 510(k) clearance K213943
Creator: U.S. Food and Drug Administration
Published: 2022-11-29

Substantially Equivalent

Smartsurgn Incorporated

FDA 510(k) clearance K213943 for SmartSurgN Visualization System, Substantially Equivalent on 2022-11-29. Applicant: Smartsurgn Incorporated. Device class: 2.

Clearance details

Applicant: Smartsurgn Incorporated
Product code: Code OWN
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 2021-12-17
Decision date: 2022-11-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Jose, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code OWN

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K254180 — PerfusiX-Imaging2026-07-24
K242163 — SmartSurgN Visualization System2026-04-20
K254242 — KARL STORZ ICG Imaging System with RUBINA® Lens2026-02-26
K251852 — cCeLL - In vivo with Drop-In Robo (CN100-2W2C488775, CN100-1W1C775, DR200)2026-02-13
K253972 — IMAGE1 (TC400US); X-to-4U Adapter (TC040)2026-02-12

Adverse events under product code OWN

product code OWN

Malfunction: 1,286
Total: 1,286

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.