Intuitive Surgical, Inc.: FDA clearances and approvals
Intuitive Surgical, Inc. has 197 FDA 510(k) clearances (first 1997, latest 2026), across 13 product codes in 6 review panels. Median 510(k) review time: 99 days. Since 2017 its median was 91 days, against 124 days for all cleared 510(k)s in the same product codes. openFDA lists 277 product recalls by a recalling firm named Intuitive Surgical, Inc. It is the industry lead sponsor of 28 device clinical trials on ClinicalTrials.gov. It files with the SEC as INTUITIVE SURGICAL INC (ISRG).
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 4 | 106 |
| 2013 | 5 | 206 |
| 2014 | 13 | 143 |
| 2015 | 6 | 70 |
| 2016 | 9 | 198 |
| 2017 | 16 | 106 |
| 2018 | 13 | 160 |
| 2019 | 10 | 88 |
| 2020 | 9 | 89 |
| 2021 | 9 | 58 |
| 2022 | 7 | 60 |
| 2023 | 7 | 87 |
| 2024 | 15 | 83 |
| 2025 | 21 | 109 |
| 2026 | 9 | 89 |
Review time against the same product codes
Since 2017, Intuitive Surgical, Inc.'s cleared 510(k)s took a median 91 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 124 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| NAY | System, Surgical, Computer Controlled Instrument | 147 | 147 |
| GCJ | Laparoscope, General & Plastic Surgery | 17 | 17 |
| EOQ | Bronchoscope (Flexible Or Rigid) | 11 | 11 |
| KCT | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | 7 | 7 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 6 | 6 |
| QIH | Automated Radiological Image Processing Software | 2 | 2 |
| FDS | Gastroscope And Accessories, Flexible/Rigid | 1 | 1 |
| GAG | Stapler, Surgical | 1 | 1 |
| HET | Laparoscope, Gynecologic (And Accessories) | 1 | 1 |
| LKF | Cannula, Manipulator/Injector, Uterine | 1 | 1 |
Plus 3 more product codes.
Review panels
- General and Plastic Surgery (172)
- Ear, Nose and Throat (11)
- General Hospital (8)
- Radiology (3)
- Obstetrics and Gynecology (2)
- Gastroenterology and Urology (1)
Most recent Intuitive Surgical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K261823 | da Vinci Surgical System, Model IS5000 | NAY | 2026-09-08 | 99 |
| K253702 | Intuitive Endoluminal Gastrointestinal System (IG1000) | FDS | 2026-08-07 | 256 |
| K261824 | da Vinci Surgical System, Model IS5000 | NAY | 2026-07-31 | 60 |
| K261249 | Universal Seal (5-12 mm) | GCJ | 2026-07-14 | 89 |
| K260695 | da Vinci Firefly Imaging System | NAY | 2026-05-22 | 80 |
| K253986 | da Vinci Force Feedback Instruments | NAY | 2026-03-11 | 89 |
| K253978 | Universal Seal (5-12 mm) | GCJ | 2026-02-24 | 74 |
| K253556 | da Vinci SP Surgical System (SP1098); da Vinci E-200 Generator | NAY | 2026-01-16 | 63 |
| K251739 | da Vinci Surgical System (IS5000) | NAY | 2026-01-16 | 224 |
| K251763 | IRISeg | QIH | 2025-12-16 | 190 |
187 earlier clearances. See the full list in Caduvo.
Recalls
277 product recalls in 122 recall events; 72 initiated in the last five years. Most recent: 2026-04-24.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Device clinical trials
Intuitive Surgical, Inc. is the industry lead sponsor of 28 device studies on ClinicalTrials.gov (10 active or recruiting). Most recent:
- NCT07259759: JURA Study - Observational First-in-human Feasibility Study (Completed, started 2025-10-31)
- NCT06923774: European Real-World Registry for Use of the Ion Endoluminal System (Recruiting, started 2025-09-09)
- NCT06308120: A Trial to Compare Robotic Assisted Bronchoscopy Ion's Clinical Utility for Peripheral Lung Nodule Access and Diagnosis to ENB (Active not recruiting, started 2024-03-20)
- NCT05867927: GENERATE - Next GENERATion of GynEcological Surgery - Robotic Assisted Surgery in Gynecological Indications (Recruiting, started 2023-10-25)
- NCT06004440: Real World Registry for Use of the Ion Endoluminal System (Active not recruiting, started 2023-09-21)
SEC filings
INTUITIVE SURGICAL INC (ISRG): EDGAR filings, CIK 1035267. Matched by exact company name.
Frequently asked questions
How many FDA 510(k) clearances does Intuitive Surgical, Inc. have?
Intuitive Surgical, Inc. has 197 FDA 510(k) clearances (first 1997, latest 2026), across 13 product codes in 6 review panels.
How long does FDA take to clear Intuitive Surgical, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Intuitive Surgical, Inc.'s cleared 510(k)s is 99 days. Since 2017: 91 days, versus 124 days for all cleared 510(k)s in the same product codes.
What devices does Intuitive Surgical, Inc. make?
Its most frequent FDA product codes are NAY (System, Surgical, Computer Controlled Instrument, 147); GCJ (Laparoscope, General & Plastic Surgery, 17); EOQ (Bronchoscope (Flexible Or Rigid), 11).
Has Intuitive Surgical, Inc. had device recalls?
openFDA lists 277 product recalls in 122 recall events by a recalling firm whose name matches Intuitive Surgical, Inc; the most recent began 2026-04-24. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 197 Intuitive Surgical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code NAY, Intuitive Surgical, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.