Intuitive Surgical, Inc. (manufacturer, Santa Clara, CA): 13 new FDA device listings, incl. laparoscope, general & plastic surgery
Intuitive Surgical, Inc. (Santa Clara, California): 13 new FDA device listings, incl. laparoscope, general & plastic surgery. Its amount of 13 is top-decile (95th percentile of 2,709 records). Dated 14 days ago, it is in the active follow-up window. Score 95/100. As of 2026-11-04, 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: 13 · 95th percentile of 2,709 DeviceEstablishmentPulse records · 6.5x the median
Free preview: all 14 published fields of this record are shown below. Locked: 309 related CA DeviceEstablishmentPulse records and the 5-column CSV export.
| 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 |
| amount percentile | 95th of 2,709 (median 2, 6.5x median) |
| Peer records CSV (310 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: 2026-10-22
- Data refreshed: 2026-11-04
- 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, 04 Nov 2026 21:52:36 GMT
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Peer benchmark and outreach value: Intuitive Surgical, Inc. and 310 California peers
- California DeviceEstablishmentPulse records like this one: 310
- Intuitive Surgical, Inc.'s amount: 95th percentile of 2,709 records
- Timing: Medium: dated in the last 30 days
- Estimated pipeline if you contact every California peer: $62,000 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
95 / 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.
- Listed in the last 45 days.
What is the DeviceEstablishmentPulse record for Intuitive Surgical, Inc. in Santa Clara, California?
Intuitive Surgical, Inc. (Santa Clara, CA), a manufacturer, added 13 FDA device listings between 2026-06-29 and 2026-10-22.
How does Intuitive Surgical, Inc. compare to other California DeviceEstablishmentPulse records?
This is a top-decile record: its amount of 13 is 6.5x the median of 2 across 2,709 records. It is fresh: dated 14 days ago, inside the window where early outreach matters most. Its Score of 95/100 puts it among the stronger signals in this feed.
Intuitive Surgical, Inc. vs. top 3 peers
| Organization | Location | Amount | Percentile | Record date |
|---|---|---|---|---|
| Intuitive Surgical, Inc. | Santa Clara, CA | 13 | 95th | 2026-10-22 |
| Masimo Corporation | Irvine, CA | 20 | 97th | 2026-10-22 |
| Inquis Medical, Inc. | Menlo Park, CA | 5 | 86th | 2026-10-16 |
| Applied Medical Resources Corp. | Rsm, CA | 3 | 77th | 2026-10-23 |
Compare Intuitive Surgical, Inc. vs Intuitive Surgical, Inc. →
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DeviceEstablishmentPulse: Manufacturer DeviceEstablishmentPulse: U.S. establishment DeviceEstablishmentPulse: records in California
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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.