Senhance Ultrasonic System— 510(k) K254192

Name: FDA 510(k) clearance K254192
Creator: U.S. Food and Drug Administration
Published: 2026-05-12

Substantially Equivalent

Asensus Surgical

FDA 510(k) clearance K254192 for Senhance Ultrasonic System, Substantially Equivalent on 2026-05-12. Applicant: Asensus Surgical. Device class: 2.

Clearance details

Applicant: Asensus Surgical
Product code: Code NAY
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 2025-12-23
Decision date: 2026-05-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Durham, NC, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code NAY

product code NAY

Death: 433
Injury: 7,927
Malfunction: 93,790
Other: 19
Total: 102,169

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.