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Senhance Surgical System

by Transenterix, Inc. 6 variants

510(k) K181517

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK181517 Date9 Oct 2018ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
NAY
Device Class
Class II
Regulation
21 CFR Part 876.1500
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 27 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Senhance Surgical System is a computer-controlled surgical instrument designed for minimally invasive laparoscopic procedures. It provides a digital platform for advanced surgical techniques in gastroenterology and urology specialties.

The system is supplied as a reusable device and is not MRI compatible. It is authorized under FDA 510K clearance with product code NAY and is intended for use in hospital settings. The system includes various components identified by specific model numbers and reference codes as listed in the registration documentation.

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