_Regulation · Permit_

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

Canonical ID: `ad93f5dc-2e9e-4148-a4cf-6dcd8163b55f`

- **Jurisdiction:** [United States](/locations/united-states.md) (id: `aa8b9c05-c836-4021-801f-59801970401e`)
- **Kind:** `permit`
- **Status (derived):** in_effect
- **Effective:** 2026-03-01

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

## Sources (1)

1. https://www.massdevice.com/revolve-surgical-fda-clearance-surgical-robot/ · 2026-03-01

## Status history

- **in_effect** · 2026-03-01 · agent-recon
    - Initial ingestion

## Common questions

### 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.


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