Senhance Surgical System— 510(k) K181517

Name: FDA 510(k) clearance K181517
Creator: U.S. Food and Drug Administration
Published: 2018-10-09

Substantially Equivalent

Transenterix, Inc.

FDA 510(k) clearance K181517 for Senhance Surgical System, Substantially Equivalent on 2018-10-09. Applicant: Transenterix, Inc.. Device class: 2.

Clearance details

Applicant: Transenterix, Inc.
Product code: Code NAY
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 2018-06-08
Decision date: 2018-10-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Morrisville, NC, US

Download summary PDF View on FDA.gov ↗

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K254192 — Senhance Ultrasonic System2026-05-12
K253986 — da Vinci Force Feedback Instruments2026-03-11

More clearances from Transenterix, Inc.

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K202166 — Senhance Surgical System2021-03-02
K200049 — Senhance Surgical System2020-03-09
K192877 — Senhance Surgical System2019-11-22
K191482 — Senhance Surgical System2019-07-11
K182421 — Senhance Ultrasonic System2019-01-11

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.