Medical Device Manufacturer · US , Sunnyvale , CA

Intuitive Surgical, Inc. - FDA 510(k) Cleared Devices

178 submissions · 158 cleared · Since 1997

Recent clearances: da Vinci Surgical System, Model IS5000, Universal Seal (5-12 mm), da Vinci Force Feedback Instruments

Official Website

178

Total

158

Cleared

0

Denied

FDA 510(k) Regulatory Record - Intuitive Surgical, Inc. Ear, Nose, Throat ✕

11 devices

1-11 of 11

Cleared Sep 23, 2025

Ion Endoluminal System (IF1000)

Ear, Nose, Throat · 85d

Cleared Sep 05, 2025

Ion Endoluminal System (IF1000)

Ear, Nose, Throat · 25d

Cleared Sep 24, 2024

Ion Endoluminal System (IF 1000)

Ear, Nose, Throat · 70d

Cleared Apr 03, 2024

Ion™ Endoluminal System (Ion™ Fully Articulating Catheter) (IF1000)

Ear, Nose, Throat · 76d

Cleared Dec 18, 2023

Ion Endoluminal System (IF1000)

Ear, Nose, Throat · 87d

Cleared Jun 16, 2022

Ion Endoluminal System (IF1000)

Ear, Nose, Throat · 134d

Cleared Aug 26, 2021

Ion Endoluminal System (Ion Fully Articulating Catheter), Ion Endoluminal...

Ear, Nose, Throat · 57d

Cleared Nov 16, 2020

Ion Endoluminal System

Ear, Nose, Throat · 89d

Cleared Jun 26, 2020

Ion Endoluminal System

Ear, Nose, Throat · 58d

Cleared Nov 26, 2019

Ion Endoluminal System

Ear, Nose, Throat · 88d

Cleared Mar 14, 2019

da Vinci SP Surgical System, EndoWrist SP Instruments, and Accessories

Ear, Nose, Throat · 195d