FDA-Cleared Surgical Robots and AI: Full List (2026)
Every few weeks, a new surgical robot or AI system announces an FDA milestone, and the headlines rarely agree on what the milestone actually was. A 510(k) clearance, a De Novo authorization, a PMA approval, and a mere submission are four very different things.
This page is the single reference for what has actually been cleared or authorized, in one place, with dates and indications. NextInSurgery maintains it and updates it in place, so the URL stays the same and the data stays current.
The numbers at a glance
Among AI-enabled devices on FDA's public list, 97 clearances fall in the surgical category (counted as of September 28, 2026):
Category | Clearances |
Surgical navigation | 31 |
Surgical planning | 27 |
GI endoscopy AI | 23 |
Intraoperative guidance and imaging | 8 |
Surgical robotics | 8 |
Total | 97 |
Source: FDA's AI-Enabled Medical Devices list, filtered to surgical use. GI endoscopy AI is included in the surgical count. This count covers AI-enabled devices only. Surgical robots without an AI designation on that list are tracked individually in the tables below.
Surgical robots
System | Pathway and date | Cleared for |
OTTAVA (Johnson & Johnson) | De Novo, Jul 22, 2026 | Upper abdominal general surgery |
Hugo RAS (Medtronic) | 510(k), Dec 3, 2025 | Urologic surgery |
Versius (CMR Surgical) | De Novo, Oct 15, 2024 | Cholecystectomy |
Versius Plus (CMR Surgical) | 510(k), Dec 17, 2025 | Cholecystectomy |
da Vinci 5 (Intuitive) | 510(k), Jan 26, 2026 | Cardiac: mitral valve repair, IMA mobilization |
Monarch (Johnson & Johnson) | 510(k), Mar 2018 | Bronchoscopy |
Dexter (Distalmotion) | De Novo, then 510(k)s, 2025 to 2026 | Hernia, cholecystectomy, gynecology |
PERLA TL, eCential Op.n (Spineart) | 510(k), Mar 2025 and Aug 2026 | Spine: pedicle screw placement |
OTTAVA: cleared for gastric bypass, gastrectomy, cholecystectomy, splenectomy, gastric sleeve, small bowel resection, appendectomy, lysis of adhesions, fundoplication and hiatal hernia repair. Table-integrated platform, controlled launch with select US customers.
Hugo RAS: cleared for prostatectomy, nephrectomy and cystectomy. Expansion to general and gynecologic indications is planned.
Versius: first multiport soft tissue general surgical robot cleared via De Novo. Versius Plus is the second generation and adds near-infrared fluorescence imaging.
da Vinci 5: announced Jan 2026, with a measured rollout to a limited number of US sites through 2026.
Monarch: the oldest system on this page, a stable baseline entry.
Dexter: each indication is its own dated clearance: hernia repair (Q4 2025), cholecystectomy (2025), hysterectomy and gynecology (Oct 2025), and a fourth gynecologic indication (2026) covering sacrocolpopexy, sacrocervicopexy, sacrohysteropexy and endometriosis resection.
PERLA TL: cleared first for navigation (Mar 13, 2025), then for robotic-assisted workflows (Aug 26, 2026).
Pending, not cleared: SSi Mantra (SS Innovations International) submitted a 510(k) on December 5, 2025 for general, urological, colorectal, gynecological, and cardiac surgery.
It had not been cleared at the time of our last check. The company chose the 510(k) route rather than De Novo and positions the system as a lower-cost platform.
Surgical AI, navigation and imaging
System | Company | Pathway | Date | Cleared for |
Proprio Paradigm | Proprio | 510(k) | Apr 2023; Picasso Jan 2026 | Spine navigation and registration |
Claire OCT | Perimeter Medical Imaging AI | PMA | Mar 3, 2026 | Breast cancer margin assessment |
Zeta Navigation System | Zeta Surgical | 510(k) | May 2026 | Neurosurgical navigation |
Zeta TMS Robotic System | Zeta Surgical | 510(k) | Jul 13, 2026 | Robotic-assisted TMS |
Proprio Paradigm: light-field imaging platform. Picasso, the fourth cleared feature, adds trace-based optical registration.
Claire OCT: formerly B-Series OCT with ImgAssist AI 2.0, PMA P250008. First AI-enabled Class III device cleared for this use.
Zeta Navigation System: includes the Stylet and Bolt instruments, with computer vision and AI-based stereotaxic navigation for catheter placement, brain biopsies and trigeminal rhizotomies.
Zeta TMS: positioning and navigation tool, with validation reported with Harvard Medical School and University of Cambridge researchers.
An adjacent milestone: autonomous blood draw
On August 19, 2026, the FDA granted De Novo authorization to Vitestro’s Aletta, the first standalone robotic device cleared to perform blood draws without hands-on operator intervention, under phlebotomist supervision.
Systems still at the research stage, with no FDA record to check against, are not listed here. We cover them in our reporting on what is coming next.
How to read FDA terms
510(k) clearance: The device is shown to be substantially equivalent to one already on the market. Most surgical robots and navigation systems follow this path.
De Novo authorization: For a new type of device with no existing comparison, but low to moderate risk. It creates a new category that later devices can use. Several newer robotic platforms entered this way.
PMA approval: The strictest path, used for higher-risk devices, with clinical evidence reviewed in depth.
Submitted or pending: Not a clearance. A company announcing a submission has not yet received anything.
How this list is built
We include systems with a verifiable FDA clearance, De Novo authorization, or PMA approval. Research prototypes are excluded.
Each entry is researched against the FDA record where one exists, not press releases alone.
New entries are added after a manual research pass whenever a clearance surfaces.
Frequently asked questions
How many surgical robots are FDA cleared? It depends on what counts as a surgical robot. The tables above track the major platforms we have verified individually, and the 97 figure covers AI-enabled surgical devices on FDA's own list. Both are updated as new records appear.
What is the difference between FDA cleared and FDA approved? Cleared usually refers to the 510(k) path. Approved refers to PMA. De Novo is called an authorization. Press coverage often mixes them up.
Does FDA clearance mean a robot is better? No. It means the device met the regulatory standard for its pathway. It says little about outcomes, cost, or adoption.
How often is this page updated? Whenever a new clearance or authorization is verified. The date at the top shows the latest update.
Cite this page
NextInSurgery. "FDA-Cleared Surgical Robots and AI Systems: The Complete List (2026)." nextinsurgery.com/fda-cleared-surgical-robots-and-ai.
