MedicalSingle-port surgical robot
da Vinci SP
by Intuitive
da Vinci SP is a surgical robot that works through one small cut, or through a natural opening such as the mouth, instead of several cuts. Its camera and instruments come out of a single tube. MedTech Dive, 18 Mar 2019
- Evidence
- Independently reported
- Human help
- Controlled by a surgeon
- Last milestone
- 15 Dec 2025
01Can I get it?
Yes, in places
- Where it works today
- Sold to hospitals in the US since 2018 and in other countries, including Korea. About 95 of the roughly 1,790 da Vinci robots Intuitive placed in 2024 were SP systems. MedTech Dive, 11 Dec 2025
- Published price
- No published price in our sources.
- Human help
- The robot does not operate on its own. A surgeon in the room sits at a console and controls the camera and instruments. Intuitive patient site
02Track record
What has actually happened
Every milestone is dated and links to the page it comes from. Lines marked company-reported rest on the maker's own word.
Cleared · sets the stage
03Safety and incidents
What has gone wrong
Intuitive started a Class 2 recall of SP instrument arm drapes (sterile covers), which could come loose from the robot arm. FDA recall database, initiated 12 May 2025
Two professors filed a petition asking the FDA to remove the robotic mastectomy use until long-term cancer safety data exist. Northeastern University School of Law, 19 Feb 2026
In clinical trials
27 registered trials
8 looking for volunteers. From ClinicalTrials.gov, read every day.
- Looking for volunteersSafety and Feasibility of Robotic SP Nipple Sparing MastectomyDeborah Farr, MD · Updated 5 Oct 2026
- Looking for volunteersMinimal ACCess Hernia InguinAlis Treatment of HerniaAlgemeen Ziekenhuis Maria Middelares · Updated 4 Sept 2026
- Looking for volunteersRobotic Single Port Ventral Hernia RepairAlgemeen Ziekenhuis Maria Middelares · Updated 21 Aug 2026
- Looking for volunteersRobotic Single Port Combined Umbilical and Inguinal Hernia RepairAlgemeen Ziekenhuis Maria Middelares · Updated 21 Aug 2026
- Looking for volunteersA Prospective, Single-Center Investigation of the da Vinci SP® Surgical System in Hepatopancreaticobiliary and Foregut Operations for Benign and Malignant DiseaseAdventHealth · Updated 11 June 2026
- Looking for volunteersApplication of da Vinci SP for Endometrial Cancer Surgical StagingNational Cancer Institute, Naples · Updated 19 Sept 2025
- Looking for volunteersProspective Study on the Use of the Da Vinci SP System in Urological SurgeryFondazione del Piemonte per l'Oncologia · Updated 22 June 2025
- Looking for volunteersSingle-Port RAS Using Da Vinci SP Surgical System for UTUC PatientsNational Taiwan University Hospital · Updated 23 May 2025
FDA record
33 FDA records
Clearances and recalls from the FDA's own database.
- 510(k) clearanceda Vinci SP Surgical System (SP1098); da Vinci E-200 Generator16 Jan 2026 · K253556
- 510(k) clearanceda Vinci SP Surgical System (SP1098)15 Dec 2025 · K252675
- Recallda Vinci SP, SP Access Port Kit, Large Incision Reference Numbers:430073 (2.7-4cm,SP1098, Box) & 430075 (2.7-7cm,SP1098,Box)15 Dec 2025
- 510(k) clearanceda Vinci SP Surgical System (SP1098)2 Dec 2025 · K252069
- 510(k) clearanceda Vinci SP Surgical System (SP1098)3 Oct 2025 · K251426
- 510(k) clearanceda Vinci SP Surgical System (SP1098)10 Sept 2025 · K251817
- 510(k) clearanceda Vinci SP Surgical System (SP1098)29 Aug 2025 · K251324
- 510(k) clearanceda Vinci SP Firefly Imaging System28 Aug 2025 · K252350
How we placed it
The rule, not an opinion
Stages are worked out by published rules from the dated milestones above. We never rate robots, and no maker can pay to change a stage.
- 5
Regulator-cleared or mass marketThis robot
A regulator has cleared it where approval applies: FDA clearance or approval for a medical robot, a permit to run with no one aboard for a self-driving vehicle, or an FAA approval for routine drone flights. Or: Widely sold: sales in the hundreds of thousands, or a product category you can buy in ordinary shops.
Placed by: Under 510(k) clearance K252675, the FDA cleared da Vinci SP for nipple-sparing mastectomy, a breast cancer operation (15 Dec 2025); The FDA cleared da Vinci SP for groin hernia repair, gallbladder removal and appendix removal (10 Dec 2025).
- 4
Paying customers
Delivered to customers who pay for it, beyond a trial, or a paid service the public can use.
- 3
Pilot
Working with a named customer in a real setting, as a trial.
- 2
Pre-orders
Orders, reservations or deposits taken, with nothing delivered yet.
- 1
Demo only
Shown in videos, staged events or a factory, with no units working for customers.
What we couldn't confirm. We did not find whether the FDA has answered the petition against the mastectomy clearance.
Sources
- 01MedTech Dive, 18 Mar 2019
- 02MedTech Dive, 11 Dec 2025
- 03Intuitive patient site
- 04Citizen petition to FDA, Feb 2026
- 05MassDevice, 2 July 2025
- 06MassDevice, 28 Apr 2023
- 07FDA recall database, initiated 12 May 2025
- 08Northeastern University School of Law, 19 Feb 2026
Cite this page
Robotics Verdict. “da Vinci SP (Intuitive): how far has it got?” roboticsverdict.com/robots/intuitive-da-vinci-sp. Checked 19 October 2026.
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