Medical Device Manufacturer · US , Sunnyvale , CA

Intuitive Surgical, Inc.

176 submissions · 156 cleared · Since 1997
176
Total
156
Cleared
0
Denied

Intuitive Surgical, Inc. — FDA 510(k) Submissions

Intuitive Surgical, Inc. has submitted 176 FDA 510(k) premarket notifications since 1997, of which 156 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include System, Surgical, Computer Controlled Instrument, Laparoscope, General & Plastic Surgery, Bronchoscope (flexible Or Rigid), Sterilization Wrap Containers, Trays, Cassettes & Other Accessories, Automated Radiological Image Processing Software . Use the specialty filter in the sidebar to narrow results.

176 devices
1–25 of 176
da Vinci Force Feedback Instruments
K253986 · NAY System, Surgical,... · General & Plastic Surgery
Mar 2026 89d
Universal Seal (5-12 mm)
K253978 · GCJ Laparoscope, General &... · General & Plastic Surgery
Feb 2026 74d
da Vinci Surgical System (IS5000)
K251739 · NAY System, Surgical,... · General & Plastic Surgery
Jan 2026 224d
da Vinci SP Surgical System (SP1098); da Vinci E-200 Generator
K253556 · NAY System, Surgical,... · General & Plastic Surgery
Jan 2026 63d
IRISeg
K251763 · QIH Automated Radiological... · Radiology
Dec 2025 190d
da Vinci SP Surgical System (SP1098)
K252675 · NAY System, Surgical,... · General & Plastic Surgery
Dec 2025 112d
da Vinci SP Surgical System (SP1098)
K252069 · NAY System, Surgical,... · General & Plastic Surgery
Dec 2025 154d
da Vinci SP Surgical System (SP1098)
K251426 · NAY System, Surgical,... · General & Plastic Surgery
Oct 2025 148d
Ion Endoluminal System (IF1000)
K252045 · EOQ Bronchoscope (flexible Or... · Ear, Nose, Throat
Sep 2025 85d
da Vinci SP Surgical System (SP1098)
K251817 · NAY System, Surgical,... · General & Plastic Surgery
Sep 2025 89d
da Vinci Surgical System (IS5000)
K251227 · NAY System, Surgical,... · General & Plastic Surgery
Sep 2025 140d
Ion Endoluminal System (IF1000)
K252528 · EOQ Bronchoscope (flexible Or... · Ear, Nose, Throat
Sep 2025 25d
da Vinci SP Surgical System (SP1098)
K251324 · NAY System, Surgical,... · General & Plastic Surgery
Aug 2025 122d
da Vinci SP Firefly Imaging System
K252350 · NAY System, Surgical,... · General & Plastic Surgery
Aug 2025 30d
da Vinci Surgical System, IS5000
K250442 · NAY System, Surgical,... · General & Plastic Surgery
Jul 2025 165d
Da Vinci Surgical System (IS5000)
K251213 · NAY System, Surgical,... · General & Plastic Surgery
Jul 2025 96d
da Vinci Surgical System (IS5000)
K251202 · NAY System, Surgical,... · General & Plastic Surgery
Jul 2025 89d
8 mm Assist Cannula; 12 mm Assist Cannula
K251490 · GCJ Laparoscope, General &... · General & Plastic Surgery
Jul 2025 49d
Vessel Sealer Curved (480522)
K250674 · NAY System, Surgical,... · General & Plastic Surgery
Jun 2025 99d
da Vinci X Surgical System (IS4200); da Vinci Xi Surgical System (IS4000)
K240852 · NAY System, Surgical,... · General & Plastic Surgery
Jun 2025 440d
SP Endoscope, 0? (430600)
K250786 · NAY System, Surgical,... · General & Plastic Surgery
May 2025 60d
da Vinci SP Surgical System (SP1098)
K243714 · NAY System, Surgical,... · General & Plastic Surgery
Apr 2025 143d
da Vinci Xi Surgical System (IS4000); da Vinci X Surgical System (IS4200)
K242427 · NAY System, Surgical,... · General & Plastic Surgery
Apr 2025 229d
da Vinci SP SureForm 45 Staplers and Reloads (SP1098)
K243596 · GAG Stapler, Surgical · General & Plastic Surgery
Mar 2025 109d
da Vinci SP Advanced Access Port Kit (432701)
K243582 · NAY System, Surgical,... · General & Plastic Surgery
Feb 2025 100d

Looking for a specific device from Intuitive Surgical, Inc.? Search by device name or K-number.

Search all Intuitive Surgical, Inc. devices
Filters