Intuitive Surgical, Inc. (manufacturer, Sunnyvale, CA): 9 new FDA device listings, incl. system, surgical, computer controlled instrument
Intuitive Surgical, Inc. (Sunnyvale, California): 9 new FDA device listings, incl. system, surgical, computer controlled instrument. Its amount of 9 is top-decile (92nd percentile of 2,570 records). Dated 49 days ago, it serves as a historical benchmark. Score 85/100. As of 2026-10-28, from openFDA device registration and listing endpoint (U.S. Food and Drug Administration).
Data as of · Compiled by Zalwin from openFDA device registration and listing endpoint (U.S. Food and Drug Administration)
amount: 9 · 92th percentile of 2,570 DeviceEstablishmentPulse records · 9.0x the median
Free preview: all 14 published fields of this record are shown below. Locked: 283 related CA DeviceEstablishmentPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Establishment | Intuitive Surgical, Inc. |
| Role | Manufacturer |
| Establishment types | Develop Specifications But Do Not Manufacture At This Facility; Manufacture Device in the United States for Export Only |
| Location | Sunnyvale, CA, US |
| New listings | 9 |
| Devices | System, Surgical, Computer Controlled Instrument; System, X-Ray, Angiographic; Laparoscope, General & Plastic Surgery; Endoscopic Video Imaging System/Component, Gastroenterology-Urology; Gastroscope And Accessories, Flexible/Rigid; Insufflator, Laparoscopic |
| Product codes | NAY, IZI, GCJ, FET, FDS, HIF |
| Device classes | Class II |
| Medical specialties | Gastroenterology, Urology, Radiology, Obstetrics/Gynecology |
| Brand names | da Vinci Surgical System, Model IS5000; da Vinci Firefly Imaging System; Intuitive Endoluminal Gastrointestinal System (IG1000); 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 | 3001675293 |
| Registration expires | 2027-12-31 |
| amount percentile | 92th of 2,570 (median 1, 9.0x median) |
| Peer records CSV (284 CA records) | 🔒 Click to unlock → |
| CRM-ready export with official source URLs | 🔒 Click to unlock → |
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CSV columns: Establishment · Role · New listings · Devices · Latest listing · official source URL
- Source agency: openFDA device registration and listing endpoint (U.S. Food and Drug Administration)
- Record date: 2026-09-16
- Data refreshed: 2026-10-28
- Refunds on request within 14 days
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LIVE PUBLIC DATA Source: openFDA device registration and listing endpoint (U.S. Food and Drug Administration) · Last refreshed: Wed, 28 Oct 2026 20:51:27 GMT
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Peer benchmark and outreach value: Intuitive Surgical, Inc. and 284 California peers
- California DeviceEstablishmentPulse records like this one: 284
- Intuitive Surgical, Inc.'s amount: 92nd percentile of 2,570 records
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every California peer: $56,800 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
85 / 100 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.
What is the DeviceEstablishmentPulse record for Intuitive Surgical, Inc. in Sunnyvale, California?
Intuitive Surgical, Inc. (Sunnyvale, CA), a manufacturer, added 9 FDA device listings between 2026-06-29 and 2026-09-16.
How does Intuitive Surgical, Inc. compare to other California DeviceEstablishmentPulse records?
This is a top-decile record: its amount of 9 is 9.0x the median of 1 across 2,570 records. It is 49 days old; check the official source for later updates before acting. Its Score of 85/100 puts it among the stronger signals in this feed.
Intuitive Surgical, Inc. vs. top 2 peers
| Organization | Location | Amount | Percentile | Record date |
|---|---|---|---|---|
| Intuitive Surgical, Inc. | Sunnyvale, CA | 9 | 92nd | 2026-09-16 |
| Inquis Medical, Inc. | Menlo Park, CA | 5 | 87th | 2026-10-16 |
| Endovascular Engineering, Inc. | Menlo Park, CA | 3 | 77th | 2026-10-14 |
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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.