Intuitive Surgical - FDA 510(k) Cleared Devices
Recent clearances: da Vinci Firefly Imaging System, da Vinci E-200 Electrosurgical Generator, Da Vinci Monopolar and Bipolar Adapters (378896)
17
Total
16
Cleared
0
Denied
FDA 510(k) Regulatory Record - Intuitive Surgical General & Plastic Surgery ✕
14 devices
Cleared
May 22, 2026
da Vinci Firefly Imaging System
General & Plastic Surgery
80d
Cleared
Aug 05, 2024
da Vinci E-200 Electrosurgical Generator
General & Plastic Surgery
60d
Cleared
Aug 02, 2024
Da Vinci Monopolar and Bipolar Adapters (378896)
General & Plastic Surgery
58d
Cleared
May 24, 2024
da Vinci Xi Surgical System (IS4000)
General & Plastic Surgery
67d
Cleared
Jun 21, 2023
da Vinci E-200 Electrosurgical Generator
General & Plastic Surgery
54d
Cleared
Nov 28, 2022
da Vinci E-200 Electrosurgical Generator
General & Plastic Surgery
60d
Cleared
Apr 29, 2020
da Vinci Xi Surgical System, da Vinci X Surgical System
General & Plastic Surgery
212d
Cleared
Feb 06, 2020
da Vinci Xi Surgical System, da Vinci X Surgical System
General & Plastic Surgery
241d
Cleared
Jul 26, 2019
da Vinci X/Xi 8mm Endoscope Plus, 0, da Vinci X/Xi 8mm Endoscope Plus, 30
General & Plastic Surgery
28d
Cleared
Jan 18, 2019
SureForm 45, SureForm 45 Reloads
General & Plastic Surgery
59d
Cleared
Jul 05, 2018
SureForm 60 and SureForm 60 Reloads
General & Plastic Surgery
212d
Cleared
Apr 29, 2016
da Vinci Xi Surgical System
General & Plastic Surgery
212d