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.

Summary

Asensus Surgical's Senhance Ultrasonic System is filed under NAY, computer controlled surgical instrument systems.

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.

Asensus filed from Durham, North Carolina. Review took 140 calendar days (December 23, 2025 to May 12, 2026).

Clearance details

Applicant: Asensus Surgical
Product code: Product 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 ↗

Recent devices under product code NAY

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K263592 — da Vinci Xi Surgical System (IS4000); da Vinci X Surgical System (IS4200)2026-10-30
K261823 — da Vinci Surgical System, Model IS50002026-09-08
K261824 — da Vinci Surgical System, Model IS50002026-07-31
K260695 — da Vinci Firefly Imaging System2026-05-22
K253986 — da Vinci Force Feedback Instruments2026-03-11

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.