Medical device manufacturer
Intuitive Surgical, Inc.
Intuitive Surgical, Inc. holds 194 FDA 510(k) clearances across 12 product codes. Median elapsed review time is 97 days. openFDA lists 277 recall records naming the company. FDA publishes it under 8 different spellings, all counted here as one company.
Updated · ingest status · JSON
- 510(k) clearances
- 194
- Product codes
- 12
- Median review
- 97 days
- Recall records
- 277
How does FDA spell Intuitive Surgical, Inc.?
FDA publishes this company under 8 different spellings across its datasets. Every figure on this page counts all of them as one company, which is why the totals here are higher than a search for any single spelling would give you.
| As FDA published it | Dataset | Matched by |
|---|---|---|
| INTUITIVE SURGICAL, INC. | device/registrationlisting | normalised |
| Intuitive Surgical | device/510k | normalised |
| Intuitive Surgical Inc | device/recall | normalised |
| Intuitive Surgical Inc | device/enforcement | normalised |
| Intuitive Surgical, Inc. | device/recall | normalised |
| Intuitive Surgical, Inc. | device/510k | normalised |
| Intuitive Surgical, Inc. | device/registrationlisting | normalised |
| Intuitive Surgical, Inc. | device/enforcement | normalised |
Merges are measured against a hand-labelled sample and held above 98% precision. Pairs the matcher is unsure of are queued for a person rather than merged, because two genuinely different firms with similar names is the error that would corrupt every count on this page.
Which product codes does Intuitive Surgical, Inc. file in?
12 product codes, ranked by how much they file in each.
| Code | Device | Clearances | Median review | Latest |
|---|---|---|---|---|
| NAY | System, Surgical, Computer Controlled Instrument | 145 | 109 days | |
| GCJ | Laparoscope, General & Plastic Surgery | 17 | 71 days | |
| EOQ | Bronchoscope (Flexible Or Rigid) | 11 | 85 days | |
| KCT | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | 7 | 199 days | |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 6 | 60 days | |
| QIH | Automated Radiological Image Processing Software | 2 | 113 days | |
| GAG | Stapler, Surgical | 1 | 109 days | |
| HET | Laparoscope, Gynecologic (And Accessories) | 1 | 63 days | |
| LKF | Cannula, Manipulator/Injector, Uterine | 1 | 141 days | |
| LLZ | System, Image Processing, Radiological | 1 | 151 days | |
| NVE | Washer, Cleaner, Automated, Endoscope | 1 | 270 days | |
| OWN | Confocal Optical Imaging | 1 | 259 days |
Median review is elapsed calendar days between date received and decision date, as published by FDA. It is not FDA review days — the two differ whenever the agency stops the clock for an additional information request.
Source: openFDA device/510k · retrieved
Has Intuitive Surgical, Inc. had a recall?
openFDA lists 277 recall records naming this company across its whole history, of which 15 were opened in the last 12 months and are not yet marked terminated. A recall record covers one firm's corrective action and may span many device lots.
Z-2310-2026Class IIOpen, ClassifiedNAY
Due to unintentionally activated near infrared handheld camera when attempting to turn off illumination during normal clinical workflow transitions, particularly when switching from the handheld camera to the robotic endoscope.
Z-2521-2026Class IIOpen, ClassifiedNAY
Operative components of surgical systems potentially distributed with E-brake retainer pin, so in event of a structural column failure, the E-brake pin would prevent E-brake engagement and may result in uncontrolled motion. In addition, if it moves/backs out it may cause restricted column range of motion and/or uncontrolled motion, which may cause patient tissue injury/crushing injury/bleeding.
Z-2046-2026Class IIOpen, ClassifiedNAY
Due to manipulator containing screws with in the arm sub-assembly that my be susceptible to breaking.
Z-1855-2026Class IOpen, ClassifiedNAY
Reloads for curved-tipped stapler may potentially produce an incomplete staple line.
Z-1355-2026Class IIOpen, ClassifiedNAY
Robotic-assisted surgical system has Viewer Display manufactured with outdated firmware, may result in loss of one display-loss of 3D surgical field (depth perception) but 2D maintained, or loss of both displays-complete visualization loss, without fault, instruments remain active, could lead to instrument contact with tissue, resulting in injury/bleeding; may require alternate surgical modality.
Showing the 5 most recently initiated of 277.
Recall class comes from openFDA's enforcement endpoint, which does not carry every recall — where it is missing, none is shown rather than guessed. Recall class I is the most serious kind of recall; device class I is the least risky kind of device, and the two are never mixed here.
Source: openFDA device/recall · retrieved
What has Intuitive Surgical, Inc. cleared recently?
| 510(k) | Device | Code | Decision | Elapsed days |
|---|---|---|---|---|
| K261249 | Universal Seal (5-12 mm) | GCJ | 89 | |
| K260695 | da Vinci Firefly Imaging System | NAY | 80 | |
| K253986 | da Vinci Force Feedback Instruments | NAY | 89 | |
| K253978 | Universal Seal (5-12 mm) | GCJ | 74 | |
| K253556 | da Vinci SP Surgical System (SP1098); da Vinci E-200 Generator | NAY | 63 | |
| K251739 | da Vinci Surgical System (IS5000) | NAY | 224 | |
| K251763 | IRISeg | QIH | 190 | |
| K252675 | da Vinci SP Surgical System (SP1098) | NAY | 112 | |
| K252069 | da Vinci SP Surgical System (SP1098) | NAY | 154 | |
| K251426 | da Vinci SP Surgical System (SP1098) | NAY | 148 |
Source: openFDA device/510k · retrieved
Where is Intuitive Surgical, Inc. registered?
FDA lists 8 registered establishments for this company in US.
Registration means the firm has told FDA it makes or distributes devices from that site. It is not a clearance, an approval or an endorsement.
Watch what Intuitive Surgical, Inc. files next
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Data on this page comes from FDA's public openFDA API and is US public domain (CC0). DeviceSignal is an independent commercial service and is not affiliated with the U.S. Food and Drug Administration. Information only, not regulatory advice. Verify anything you rely on against open.fda.gov.