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Intuitive Surgical, Inc. FDA Approvals
0 new drug approvals and 62 device clearances on file. Matched by name to ISRG.
Newest first
A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.
| Product |
|---|
| da Vinci Surgical System, Model IS5000510(k)Sep 8, 2026Gastroenterology, Urology |
| Intuitive Endoluminal Gastrointestinal System (IG1000)510(k)Aug 7, 2026Gastroenterology, Urology |
| da Vinci Surgical System, Model IS5000510(k)Jul 31, 2026Gastroenterology, Urology |
| Universal Seal (5-12 mm)510(k)Jul 14, 2026Gastroenterology, Urology |
| da Vinci Force Feedback Instruments510(k)Mar 11, 2026Gastroenterology, Urology |
| Universal Seal (5-12 mm)510(k)Feb 24, 2026Gastroenterology, Urology |
| da Vinci Surgical System (IS5000)510(k)Jan 16, 2026Gastroenterology, Urology |
| da Vinci SP Surgical System (SP1098); da Vinci E-200 Generator510(k)Jan 16, 2026Gastroenterology, Urology |
| IRISeg510(k)Dec 16, 2025Radiology |
| da Vinci SP Surgical System (SP1098)510(k)Dec 15, 2025Gastroenterology, Urology |
| da Vinci SP Surgical System (SP1098)510(k)Dec 2, 2025Gastroenterology, Urology |
| da Vinci SP Surgical System (SP1098)510(k)Oct 3, 2025Gastroenterology, Urology |
| Ion Endoluminal System (IF1000)510(k)Sep 23, 2025Ear, Nose, Throat |
| da Vinci SP Surgical System (SP1098)510(k)Sep 10, 2025Gastroenterology, Urology |
| da Vinci Surgical System (IS5000)510(k)Sep 8, 2025Gastroenterology, Urology |
| Ion Endoluminal System (IF1000)510(k)Sep 5, 2025Ear, Nose, Throat |
| da Vinci SP Surgical System (SP1098)510(k)Aug 29, 2025Gastroenterology, Urology |
| da Vinci SP Firefly Imaging System510(k)Aug 28, 2025Gastroenterology, Urology |
| da Vinci Surgical System, IS5000510(k)Jul 29, 2025Gastroenterology, Urology |
| Da Vinci Surgical System (IS5000)510(k)Jul 23, 2025Gastroenterology, Urology |
| da Vinci Surgical System (IS5000)510(k)Jul 16, 2025Gastroenterology, Urology |
| 8 mm Assist Cannula; 12 mm Assist Cannula510(k)Jul 2, 2025Gastroenterology, Urology |
| Vessel Sealer Curved (480522)510(k)Jun 13, 2025Gastroenterology, Urology |
| da Vinci X Surgical System (IS4200); da Vinci Xi Surgical System (IS4000)510(k)Jun 11, 2025Gastroenterology, Urology |
| SP Endoscope, 0° (430600)510(k)May 13, 2025Gastroenterology, Urology |
| da Vinci SP Surgical System (SP1098)510(k)Apr 24, 2025Gastroenterology, Urology |
| da Vinci Xi Surgical System (IS4000); da Vinci X Surgical System (IS4200)510(k)Apr 1, 2025Gastroenterology, Urology |
| da Vinci SP SureForm 45 Staplers and Reloads (SP1098)510(k)Mar 10, 2025General Hospital |
| da Vinci SP Advanced Access Port Kit (432701)510(k)Feb 28, 2025Gastroenterology, Urology |
| da Vinci Surgical System (IS5000)510(k)Dec 16, 2024Gastroenterology, Urology |
| IRISeg510(k)Dec 10, 2024Radiology |
| da Vinci SP Surgical System (SP1098)510(k)Nov 26, 2024Gastroenterology, Urology |
| da Vinci SP Instruments (SP1098)510(k)Nov 18, 2024Gastroenterology, Urology |
| Ion Endoluminal System (IF 1000)510(k)Sep 24, 2024Ear, Nose, Throat |
| 8mm SureForm 30 Curved-Tip Stapler; 8mm SureForm 30 Stapler; 8mm SureForm 30 Reloads510(k)Sep 10, 2024Gastroenterology, Urology |
| Universal Seal (5-12 mm)510(k)Aug 5, 2024Gastroenterology, Urology |
| da Vinci SP Surgical System (SP1098)510(k)Jul 8, 2024Gastroenterology, Urology |
| da Vinci Surgical System (IS5000)510(k)Jul 3, 2024Gastroenterology, Urology |
| da Vinci SP Surgical System (SP1098)510(k)Jun 4, 2024Gastroenterology, Urology |
| Ion Endoluminal System (Ion Fully Articulating Catheter) (IF1000)510(k)Apr 3, 2024Ear, Nose, Throat |
| da Vinci Surgical System Model IS5000, da Vinci Insufflator and Tube Set with Smoke Evacuation510(k)Mar 14, 2024Gastroenterology, Urology |
| Ion Endoluminal System (IF1000)510(k)Dec 18, 2023Ear, Nose, Throat |
| da Vinci SP Surgical System510(k)Nov 8, 2023Gastroenterology, Urology |
| Universal Seal (5-12 mm)510(k)Jul 5, 2023Gastroenterology, Urology |
| da Vinci Xi Surgical System (IS4000), da Vinci X Surgical System (IS4200)510(k)May 12, 2023Gastroenterology, Urology |
| Da Vinci SP Surgical System (SP1098)510(k)Apr 5, 2023Gastroenterology, Urology |
| EndoWrist Stapler 30 System, EndoWrist Stapler 45 System, SureForm 45 System, SureForm 60 System, 8 mm SureForm 30 System510(k)Mar 16, 2023Gastroenterology, Urology |
| da Vinci X Surgical System (IS4200), da Vinci Xi Surgical System (IS4000)510(k)Nov 22, 2022Gastroenterology, Urology |
| da Vinci Firefly Imaging System510(k)Oct 20, 2022Gastroenterology, Urology |
| da Vinci X/Xi (IS4200/IS4000) 8mm Reusable Instruments510(k)Aug 15, 2022Gastroenterology, Urology |
| Ion Endoluminal System (IF1000)510(k)Jun 16, 2022Ear, Nose, Throat |
| da Vinci Fluorescence Imaging Vision System, da Vinci Firefly Imaging System510(k)Feb 17, 2022Gastroenterology, Urology |
| 8mm Monopolar Curved Scissors510(k)Jan 31, 2022Gastroenterology, Urology |
| 8 mm SureForm 30 Curved-Tip Stapler, 8 mm SureForm 30 Stapler, SureForm 30 Reloads510(k)Dec 10, 2021Gastroenterology, Urology |
| da Vinci SP Firefly Imaging System510(k)Nov 23, 2021Gastroenterology, Urology |
| Da Vinci SP Surgical System510(k)Sep 29, 2021Gastroenterology, Urology |
| Ion Endoluminal System (Ion Fully Articulating Catheter), Ion Endoluminal System (Ion Peripheral Vision Probe)510(k)Aug 26, 2021Ear, Nose, Throat |
| da Vinci Xi Surgical System (IS4000), da Vinci X Surgical System (IS4200)510(k)Aug 6, 2021Gastroenterology, Urology |
| da Vinci SP Surgical System (SP1098)510(k)Jul 23, 2021Gastroenterology, Urology |
| da Vinci SP Surgical System (SP1098)510(k)Jun 23, 2021Gastroenterology, Urology |
| da Vinci Fluorescence Imaging Vision System, da Vinci Firefly Imaging System510(k)Apr 26, 2021Gastroenterology, Urology |
| da Vinci S/Si (IS2000/IS3000) 5mm and 8mm Reusable Instruments, da Vinci Xi/X (IS4000/IS4200) 8mm Reusable Instruments510(k)Feb 10, 2021Gastroenterology, Urology |