# Intuitive Surgical, Inc. (manufacturer, Santa Clara, CA): 13 new FDA device listings, incl. laparoscope, general & plastic surgery

**Score:** 95/100

| 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 | 13 |
| Devices | Laparoscope, General & Plastic Surgery; System, Surgical, Computer Controlled Instrument; Insufflator, Laparoscopic; System, X-Ray, Angiographic; Endoscopic Video Imaging System/Component, Gastroenterology-Urology; Gastroscope And Accessories, Flexible/Rigid; Sterilization Wrap Containers, Trays, Cassettes & Other Accessories |
| Product codes | GCJ, NAY, HIF, IZI, FET, FDS, KCT |
| Device classes | Class II |
| Medical specialties | Gastroenterology, Urology, Obstetrics/Gynecology, Radiology, General Hospital |
| Brand names | Universal Seal; da Vinci Surgical System, Model IS5000; CO2 Tank Gas Accessory, CGA 940; CO2 Tank Gas Accessory, ISO 407; CO2 Tank Gas Accessory, DIN 477; CO2 Tank Gas Accessory, ISO 5145; da Vinci Firefly Imaging System; Intuitive Endoluminal Gastrointestinal System (IG1000) |
| First new listing | 2026-06-29 |
| Latest new listing | 2026-10-22 |
| 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.
- Listed in the last 45 days.

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: 2026-11-04T21:52:36.524Z.
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.