FDA 510(k) Clearance: Revolve Surgical Electromechanical Laparoscopic Surgery Robot

[in effect]

United States · permit · permit

All Policies

Jurisdiction

United States

Classification

permit

Status

in effect

Effective Date

Mar 1, 2026

Primary Sources

1 audited

Statutory Scope & Summary

FDA cleared the Revolve Surgical robot platform (K243968), an electromechanically controlled laparoscopic surgery platform for minimally invasive abdominal surgery.

Covered Sectors & Application Domains

Service & Cobot Robotics/

Regulatory Analysis & Inquiries

6 entries

What does FDA 510(k) Clearance: Revolve Surgical Electromechanical Laparoscopic Surgery Robot cover?

FDA cleared the Revolve Surgical robot platform (K243968), an electromechanically controlled laparoscopic surgery platform for minimally invasive abdominal surgery.

Where does FDA 510(k) Clearance: Revolve Surgical Electromechanical Laparoscopic Surgery Robot apply?

FDA 510(k) Clearance: Revolve Surgical Electromechanical Laparoscopic Surgery Robot is recorded as a permitting requirement applying in United States on the DEPLOY registry.

When did FDA 510(k) Clearance: Revolve Surgical Electromechanical Laparoscopic Surgery Robot take effect?

FDA 510(k) Clearance: Revolve Surgical Electromechanical Laparoscopic Surgery Robot is recorded as effective March 1, 2026 on the DEPLOY registry.

Is FDA 510(k) Clearance: Revolve Surgical Electromechanical Laparoscopic Surgery Robot still in effect?

FDA 510(k) Clearance: Revolve Surgical Electromechanical Laparoscopic Surgery Robot is currently in effect and applies to covered operators in the named jurisdiction.

What types of robots does FDA 510(k) Clearance: Revolve Surgical Electromechanical Laparoscopic Surgery Robot apply to?

FDA 510(k) Clearance: Revolve Surgical Electromechanical Laparoscopic Surgery Robot is recorded as applying to surgical on the DEPLOY registry.

Which robot models on the DEPLOY registry fall under FDA 510(k) Clearance: Revolve Surgical Electromechanical Laparoscopic Surgery Robot?

8 robot models on the DEPLOY registry match the form-factor scope of FDA 510(k) Clearance: Revolve Surgical Electromechanical Laparoscopic Surgery Robot: ANOVO, Andromeda Surgical Robot, CORI, Carina and 4 others. Form-factor scope match does not by itself establish compliance status; review the underlying primary sources for each operator.

Primary Sources & Legal Instruments

1 document

https://www.massdevice.com/revolve-surgical-fda-clearance-surgical-robot/
https://www.massdevice.com/revolve-surgical-fda-clearance-surgical-robot/
Official Source