Intuitive Surgical, Inc. - FDA 510(k) Cleared Devices
182
Total
162
Cleared
0
Denied
182 devices
Cleared
Jun 11, 2025
da Vinci X Surgical System (IS4200)
General & Plastic Surgery
440d
Cleared
May 13, 2025
SP Endoscope, 0° (430600)
General & Plastic Surgery
60d
Cleared
Apr 24, 2025
da Vinci SP Surgical System (SP1098)
General & Plastic Surgery
143d
Cleared
Apr 01, 2025
da Vinci Xi Surgical System (IS4000)
General & Plastic Surgery
229d
Cleared
Mar 10, 2025
da Vinci SP SureForm 45 Staplers and Reloads (SP1098)
General & Plastic Surgery
109d
Cleared
Feb 28, 2025
da Vinci SP Advanced Access Port Kit (432701)
General & Plastic Surgery
100d
Cleared
Dec 16, 2024
da Vinci Surgical System (IS5000)
General & Plastic Surgery
20d
Cleared
Dec 10, 2024
IRISeg
Radiology
113d
Cleared
CT
Nov 26, 2024
da Vinci SP Surgical System (SP1098)
General & Plastic Surgery
113d
Cleared
Nov 18, 2024
da Vinci SP Instruments (SP1098)
General & Plastic Surgery
147d
Cleared
Sep 24, 2024
Ion Endoluminal System (IF 1000)
Ear, Nose, Throat
70d
Cleared
Sep 10, 2024
8mm SureForm 30 Curved-Tip Stapler
General & Plastic Surgery
95d
Cleared
Aug 05, 2024
Universal Seal (5-12 mm)
General & Plastic Surgery
83d
Cleared
CT
Jul 08, 2024
da Vinci SP Surgical System (SP1098)
General & Plastic Surgery
138d
Cleared
Jul 03, 2024
da Vinci Surgical System (IS5000)
General & Plastic Surgery
57d
Cleared
Jun 04, 2024
da Vinci SP Surgical System (SP1098)
General & Plastic Surgery
267d
Cleared
Apr 03, 2024
Ion™ Endoluminal System (Ion™ Fully Articulating Catheter) (IF1000)
Ear, Nose, Throat
76d
Cleared
CT
Mar 14, 2024
da Vinci Surgical System Model IS5000, da Vinci Insufflator and Tube Set with...
General & Plastic Surgery
199d
Cleared
Dec 18, 2023
Ion Endoluminal System (IF1000)
Ear, Nose, Throat
87d
Cleared
Nov 08, 2023
da Vinci SP Surgical System
General & Plastic Surgery
141d
Cleared
Jul 05, 2023
Universal Seal (5-12 mm)
General & Plastic Surgery
56d
Cleared
May 12, 2023
da Vinci Xi Surgical System (IS4000), da Vinci X Surgical System (IS4200)
General & Plastic Surgery
14d
Cleared
Apr 05, 2023
Da Vinci SP Surgical System (SP1098)
General & Plastic Surgery
90d
Cleared
Mar 16, 2023
EndoWrist Stapler 30 System, EndoWrist Stapler 45 System, SureForm 45 System,...
General & Plastic Surgery
177d
Cleared
Nov 22, 2022
da Vinci X Surgical System (IS4200), da Vinci Xi Surgical System (IS4000)
General & Plastic Surgery
53d
Looking for a specific device from Intuitive Surgical, Inc.? Search by device name or K-number.
Search all Intuitive Surgical, Inc. devices