Senhance Surgical System
by Transenterix, Inc. 6 variants
510(k) K191482
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK191482 | Date11 Jul 2019 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 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, 1 Oct 2026
The Senhance Surgical System is a computer-controlled surgical instrument designed for minimally invasive procedures. It integrates robotic-assisted technology to enhance precision and control during laparoscopic surgeries, particularly in gastroenterology and urology. The system provides real-time imaging and manipulation capabilities, enabling surgeons to perform complex procedures with improved dexterity and visualization.
This system is supplied as a reusable medical device and is intended for use in controlled surgical environments. It is not MRI-safe and requires proper sterilization and maintenance protocols. The device is authorized under FDA 510(k) clearance (K191482) and falls under Class II regulatory classification. Storage and handling must adhere to manufacturer guidelines to ensure optimal performance and sterility.
Other devices from Transenterix, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the Senhance Surgical System used for?
The Senhance Surgical System is designed for minimally invasive laparoscopic surgeries, specifically in gastroenterology and urology. It integrates robotic-assisted technology to enhance precision, control, and visualization during complex procedures, allowing surgeons to perform tasks with greater dexterity and accuracy than traditional laparoscopic tools.
Is the Senhance Surgical System reusable or single-use?
The Senhance Surgical System is a reusable medical device. It is intended for use in controlled surgical environments and requires proper sterilization and maintenance protocols to ensure performance and sterility between procedures. Reusability helps reduce waste and costs while maintaining high standards of safety.
Can the Senhance Surgical System be used in an MRI environment?
No, the Senhance Surgical System is not MRI-safe. This means it should not be used in or near MRI machines, as the magnetic fields could interfere with the device’s operation or pose safety risks to patients and staff. Always verify compatibility with imaging equipment before use.
What regulatory approval does the Senhance Surgical System hold?
The Senhance Surgical System holds FDA 510(k) clearance (K191482) and is classified as a Class II medical device. This clearance indicates that the device is deemed substantially equivalent to a legally marketed predicate device, meeting regulatory standards for safety and effectiveness in its intended use for minimally invasive surgeries.
How should the Senhance Surgical System be stored and maintained?
The Senhance Surgical System must be stored and handled according to the manufacturer’s guidelines to ensure optimal performance and sterility. Proper storage includes keeping the device in a clean, dry environment away from direct sunlight or extreme temperatures. Maintenance protocols, such as regular cleaning, sterilization, and inspection, are critical to prevent contamination and ensure reliable operation during surgical procedures.