Senhance Surgical System— 510(k) K223095

Name: FDA 510(k) clearance K223095
Creator: U.S. Food and Drug Administration
Published: 2023-03-16

Substantially Equivalent

Asensus Surgical, Inc.

FDA 510(k) clearance K223095 for Senhance Surgical System, Substantially Equivalent on 2023-03-16. Applicant: Asensus Surgical, Inc.. Device class: 2.

Clearance details

Applicant: Asensus Surgical, Inc.
Product code: Code NAY
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 2022-09-30
Decision date: 2023-03-16
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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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
K254192 — Senhance Ultrasonic System2026-05-12
K253986 — da Vinci Force Feedback Instruments2026-03-11

More clearances from Asensus Surgical, Inc.

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K233866 — Senhance Surgical System2024-07-19
K220889 — Senhance Surgical System2022-05-27
K212054 — Senhance Surgical System2021-08-30
K211325 — Senhance Surgical System2021-07-27

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 →

Recalls naming K223095

K-number listed on FDA's recall record

Z-0170-2024 — Senhance Surgical System, which includes: Manipulator Arm, ISU Configuration ( Catalog Number X9007708), Intelligent Surgical Unit (Catalog Number X9007696), and Cockpit, ISU Configuration (Catalog Number X9007707), Software (SW) version 2.7.4; robotic surgical systemClass I·Terminated·Asensus Surgical Inc·20230915

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K223095.

Data sourced from openFDA. This site is unofficial and independent of the FDA.