# Intuitive Surgical, Inc. (manufacturer, Santa Clara, CA): 9 new FDA device listings, incl. system, surgical, computer controlled instrument

**Score:** 85/100

| Field | Value |
|---|---|
| Establishment | Intuitive Surgical, Inc. |
| Role | Manufacturer |
| Establishment types | Complaint File Establishment per 21 CFR 820.198; Manufacture Device in the United States for Export Only |
| Location | Santa Clara, CA, US |
| New listings | 9 |
| Devices | System, Surgical, Computer Controlled Instrument; Endoscopic Video Imaging System/Component, Gastroenterology-Urology; Gastroscope And Accessories, Flexible/Rigid; System, X-Ray, Angiographic; Laparoscope, General & Plastic Surgery; Insufflator, Laparoscopic |
| Product codes | NAY, FET, FDS, IZI, GCJ, HIF |
| Device classes | Class II |
| Medical specialties | Gastroenterology, Urology, Radiology, Obstetrics/Gynecology |
| Brand names | da Vinci Surgical System, Model IS5000; Intuitive Endoluminal Gastrointestinal System (IG1000); da Vinci Firefly Imaging System; Universal Seal; CO2 Tank Gas Accessory, ISO 5145; CO2 Tank Gas Accessory, ISO 407; CO2 Tank Gas Accessory, DIN 477; CO2 Tank Gas Accessory, CGA 940 |
| First new listing | 2026-06-29 |
| Latest new listing | 2026-09-16 |
| FDA registration number | 3015612252 |
| Registration expires | 2027-12-31 |

## Why this score
- Brings its own devices to market: buys manufacturing, sterilization and QMS help.
- Class II or III devices: QMS and regulatory demands.
- Several new listings at once.
- U.S. establishment.

Source: openFDA device registration and listing endpoint (U.S. Food and Drug Administration) (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm). Last refreshed: 2026-10-28T20:51:27.468Z.
From the openFDA device registration and listing data, refreshed weekly. A listing shows a device an establishment says it makes or handles for the U.S. market; it is not FDA clearance or approval. Contact persons and street addresses are not stored. Verify in the FDA Establishment Registration and Device Listing database.