Ion Endoluminal System (IF1000)
Intuitive Surgical, Inc.
INTUITIVE SURGICAL, INC.
FDA Registration(s)
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 2955842 | 3008615487 | INTUITIVE SURGICAL, INC. | 1 | N | 2026-01-01 | 950 Kifer Road SUNNYVALE CA US 94086 |
| 3001675293 | 3001675293 | INTUITIVE SURGICAL, INC. | 1 | N | 2026-01-01 | 1266 Kifer Road Sunnyvale CA US 94086 |
| 3007531906 | 3007531906 | INTUITIVE SURGICAL, INC. | 1 | Y | 2026-01-01 | 1450 Kifer Road Sunnyvale CA US 94086 |
| 3013942591 | 3013942591 | INTUITIVE SURGICAL, INC. | 1 | N | 2026-01-01 | 1090 Kifer Road Sunnyvale CA US 94086 |
| 3015241782 | 3015241782 | Intuitive Surgical, Inc. | 1 | Y | 2026-01-01 | 4550 W Watkins Street Suite 120 Phoenix AZ US 85043 |
| 3015612252 | 3015612252 | INTUITIVE SURGICAL, INC. | 1 | Y | 2026-01-01 | 3410 Central Expressway -- Santa Clara CA US 95051 |
| 3018126215 | 3018126215 | Intuitive Surgical, Inc. | 1 | N | 2026-01-01 | 1050 Kifer Road Sunnyvale CA US 94086 |
| 3022626486 | 3022626486 | Intuitive Surgical, Inc. | 1 | N | 2026-01-01 | 3795 Data Dr Peachtree Corners GA US 30092 |
| 3038182369 | 3038182369 | INTUITIVE SURGICAL, INC. | 1 | N | 2026-01-01 | 3859 Kifer Road -- Santa Clara CA US 95051 |
| 3012249465 | 3012249465 | Intuitive Surgical, Inc. | 1 | N | 2020-04-25 | 710 Venture Dr, Suite 300 DeSoto Trade Center Building 1 Southaven MS US 38672 |
| 3015527853 | 3015527853 | INTUITIVE SURGICAL, INC. | 1 | N | 2020-04-25 | 1650 TW Alexander Drive -- Durham NC US 27703 |
Registered Device Listings
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 231702 | 1649676110 | K990144 | INTUITIVE SURGICAL ENDOSCOPIC INSTRUMENTS, INTUITIVE SURGICAL ENDOSCOPIC INSTRUMENT CONTROL SYSTEM | NAY | 2000-07-11 |
| 226106 | 1649676110 | K990144 | INTUITIVE SURGICAL ENDOSCOPIC INSTRUMENTS, INTUITIVE SURGICAL ENDOSCOPIC INSTRUMENT CONTROL SYSTEM | NAY | 2000-07-11 |
| 157116 | 1649676110 | K990144 | INTUITIVE SURGICAL ENDOSCOPIC INSTRUMENTS, INTUITIVE SURGICAL ENDOSCOPIC INSTRUMENT CONTROL SYSTEM | NAY | 2000-07-11 |
| 125283 | 1649676110 | K990144 | INTUITIVE SURGICAL ENDOSCOPIC INSTRUMENTS, INTUITIVE SURGICAL ENDOSCOPIC INSTRUMENT CONTROL SYSTEM | NAY | 2000-07-11 |
| 289340 | 1599223762 | K253986 | da Vinci Force Feedback Instruments | NAY | 2026-03-11 |
| 231702 | 1599223762 | K253986 | da Vinci Force Feedback Instruments | NAY | 2026-03-11 |
| 125283 | 1599223762 | K253986 | da Vinci Force Feedback Instruments | NAY | 2026-03-11 |
| 305563 | 1365162556 | K253978 | Universal Seal (5-12 mm) | GCJ | 2026-02-24 |
| 289340 | 1365162556 | K253978 | Universal Seal (5-12 mm) | GCJ | 2026-02-24 |
| 231702 | 1365162556 | K253978 | Universal Seal (5-12 mm) | GCJ | 2026-02-24 |
| 125283 | 1365162556 | K253978 | Universal Seal (5-12 mm) | GCJ | 2026-02-24 |
| 305563 | 1867016052 | K253556 | da Vinci SP Surgical System (SP1098); da Vinci E-200 Generator | NAY | 2026-01-16 |
| 289340 | 1867016052 | K253556 | da Vinci SP Surgical System (SP1098); da Vinci E-200 Generator | NAY | 2026-01-16 |
| 231702 | 1867016052 | K253556 | da Vinci SP Surgical System (SP1098); da Vinci E-200 Generator | NAY | 2026-01-16 |
| 125283 | 1867016052 | K253556 | da Vinci SP Surgical System (SP1098); da Vinci E-200 Generator | NAY | 2026-01-16 |
| 16862 | 1867016052 | K253556 | da Vinci SP Surgical System (SP1098); da Vinci E-200 Generator | NAY | 2026-01-16 |
| 231702 | 1854948102 | K252675 | da Vinci SP Surgical System (SP1098) | NAY | 2025-12-15 |
| 125283 | 1854948102 | K252675 | da Vinci SP Surgical System (SP1098) | NAY | 2025-12-15 |
| 231702 | 2066108222 | K252528 | Ion Endoluminal System (IF1000) | EOQ | 2025-09-05 |
| 125283 | 2066108222 | K252528 | Ion Endoluminal System (IF1000) | EOQ | 2025-09-05 |
| 125283 | 1810999774 | K252350 | da Vinci SP Firefly Imaging System | NAY | 2025-08-28 |
| 231702 | 1810999774 | K252350 | da Vinci SP Firefly Imaging System | NAY | 2025-08-28 |
| 231702 | 1712454783 | K252069 | da Vinci SP Surgical System (SP1098) | NAY | 2025-12-02 |
| 125283 | 1712454783 | K252069 | da Vinci SP Surgical System (SP1098) | NAY | 2025-12-02 |
| 338411 | 1549988286 | K252045 | Ion Endoluminal System (IF1000) | EOQ | 2025-09-23 |
| 231702 | 1549988286 | K252045 | Ion Endoluminal System (IF1000) | EOQ | 2025-09-23 |
| 125283 | 1549988286 | K252045 | Ion Endoluminal System (IF1000) | EOQ | 2025-09-23 |
| 231702 | 1006620017 | K251817 | da Vinci SP Surgical System (SP1098) | NAY | 2025-09-10 |
| 125283 | 1006620017 | K251817 | da Vinci SP Surgical System (SP1098) | NAY | 2025-09-10 |
| 231702 | 1376234761 | K251763 | IRISeg | QIH | 2025-12-16 |
| 125283 | 1376234761 | K251763 | IRISeg | QIH | 2025-12-16 |
| 231702 | 1609270087 | K251739 | da Vinci Surgical System (IS5000) | NAY | 2026-01-16 |
| 125283 | 1609270087 | K251739 | da Vinci Surgical System (IS5000) | NAY | 2026-01-16 |
| 231702 | 1078043608 | K251490 | 8 mm Assist Cannula; 12 mm Assist Cannula | GCJ | 2025-07-02 |
| 125283 | 1078043608 | K251490 | 8 mm Assist Cannula; 12 mm Assist Cannula | GCJ | 2025-07-02 |
| 231702 | 1049792656 | K251426 | da Vinci SP Surgical System (SP1098) | NAY | 2025-10-03 |
| 125283 | 1049792656 | K251426 | da Vinci SP Surgical System (SP1098) | NAY | 2025-10-03 |
| 231702 | 1919202686 | K251324 | da Vinci SP Surgical System (SP1098) | NAY | 2025-08-29 |
| 125283 | 1919202686 | K251324 | da Vinci SP Surgical System (SP1098) | NAY | 2025-08-29 |
| 231702 | 1303186815 | K251227 | da Vinci Surgical System (IS5000) | NAY | 2025-09-08 |
| 125283 | 1303186815 | K251227 | da Vinci Surgical System (IS5000) | NAY | 2025-09-08 |
| 231702 | 1901361647 | K251213 | Da Vinci Surgical System (IS5000) | NAY | 2025-07-23 |
| 125283 | 1901361647 | K251213 | Da Vinci Surgical System (IS5000) | NAY | 2025-07-23 |
| 231702 | 1527576799 | K251202 | da Vinci Surgical System (IS5000) | NAY | 2025-07-16 |
| 125283 | 1527576799 | K251202 | da Vinci Surgical System (IS5000) | NAY | 2025-07-16 |
| 231702 | 1327445930 | K250786 | SP Endoscope, 0° (430600) | NAY | 2025-05-13 |
| 125283 | 1327445930 | K250786 | SP Endoscope, 0° (430600) | NAY | 2025-05-13 |
| 16862 | 1327445930 | K250786 | SP Endoscope, 0° (430600) | NAY | 2025-05-13 |
| 125283 | 1667031296 | K250674 | Vessel Sealer Curved (480522) | NAY | 2025-06-13 |
| 231702 | 1667031296 | K250674 | Vessel Sealer Curved (480522) | NAY | 2025-06-13 |
| 289340 | 1667031296 | K250674 | Vessel Sealer Curved (480522) | NAY | 2025-06-13 |
| 305563 | 1667031296 | K250674 | Vessel Sealer Curved (480522) | NAY | 2025-06-13 |
| 231702 | 1749021172 | K250442 | da Vinci Surgical System, IS5000 | NAY | 2025-07-29 |
| 125283 | 1749021172 | K250442 | da Vinci Surgical System, IS5000 | NAY | 2025-07-29 |
| 231702 | 1983136713 | K243714 | da Vinci SP Surgical System (SP1098) | NAY | 2025-04-24 |
| 125283 | 1983136713 | K243714 | da Vinci SP Surgical System (SP1098) | NAY | 2025-04-24 |
| 305563 | 1734258843 | K243641 | da Vinci Surgical System (IS5000) | NAY | 2024-12-16 |
| 289340 | 1734258843 | K243641 | da Vinci Surgical System (IS5000) | NAY | 2024-12-16 |
| 231702 | 1734258843 | K243641 | da Vinci Surgical System (IS5000) | NAY | 2024-12-16 |
| 125283 | 1734258843 | K243641 | da Vinci Surgical System (IS5000) | NAY | 2024-12-16 |
| 231702 | 1081307214 | K243596 | da Vinci SP SureForm 45 Staplers and Reloads (SP1098) | GAG | 2025-03-10 |
| 125283 | 1081307214 | K243596 | da Vinci SP SureForm 45 Staplers and Reloads (SP1098) | GAG | 2025-03-10 |
| 16862 | 1081307214 | K243596 | da Vinci SP SureForm 45 Staplers and Reloads (SP1098) | GAG | 2025-03-10 |
| 231702 | 1277276069 | K243582 | da Vinci SP Advanced Access Port Kit (432701) | NAY | 2025-02-28 |
| 125283 | 1277276069 | K243582 | da Vinci SP Advanced Access Port Kit (432701) | NAY | 2025-02-28 |
| 16862 | 1277276069 | K243582 | da Vinci SP Advanced Access Port Kit (432701) | NAY | 2025-02-28 |
| 231702 | 1550977271 | K242461 | IRISeg | QIH | 2024-12-10 |
| 125283 | 1550977271 | K242461 | IRISeg | QIH | 2024-12-10 |
| 231702 | 1943002341 | K242427 | da Vinci Xi Surgical System (IS4000); da Vinci X Surgical System (IS4200) | NAY | 2025-04-01 |
| 125283 | 1943002341 | K242427 | da Vinci Xi Surgical System (IS4000); da Vinci X Surgical System (IS4200) | NAY | 2025-04-01 |
| 231702 | 1688829305 | K242318 | da Vinci SP Surgical System (SP1098) | NAY | 2024-11-26 |
| 125283 | 1688829305 | K242318 | da Vinci SP Surgical System (SP1098) | NAY | 2024-11-26 |
| 231702 | 1747157771 | K242070 | Ion Endoluminal System (IF 1000) | EOQ | 2024-09-24 |
| 125283 | 1747157771 | K242070 | Ion Endoluminal System (IF 1000) | EOQ | 2024-09-24 |
| 305563 | 1326700674 | K241913 | da Vinci Handheld Camera | GCJ | 2024-08-28 |
| 231702 | 1326700674 | K241913 | da Vinci Handheld Camera | GCJ | 2024-08-28 |
| 125283 | 1326700674 | K241913 | da Vinci Handheld Camera | GCJ | 2024-08-28 |
| 305563 | 1936952756 | K241814 | da Vinci SP Instruments (SP1098) | NAY | 2024-11-18 |
| 231702 | 1936952756 | K241814 | da Vinci SP Instruments (SP1098) | NAY | 2024-11-18 |
| 125283 | 1936952756 | K241814 | da Vinci SP Instruments (SP1098) | NAY | 2024-11-18 |
| 16862 | 1936952756 | K241814 | da Vinci SP Instruments (SP1098) | NAY | 2024-11-18 |
| 305563 | 1770965988 | K241638 | 8mm SureForm 30 Curved-Tip Stapler; 8mm SureForm 30 Stapler; 8mm SureForm 30 Reloads | NAY | 2024-09-10 |
| 289340 | 1770965988 | K241638 | 8mm SureForm 30 Curved-Tip Stapler; 8mm SureForm 30 Stapler; 8mm SureForm 30 Reloads | NAY | 2024-09-10 |
| 231702 | 1770965988 | K241638 | 8mm SureForm 30 Curved-Tip Stapler; 8mm SureForm 30 Stapler; 8mm SureForm 30 Reloads | NAY | 2024-09-10 |
| 125283 | 1770965988 | K241638 | 8mm SureForm 30 Curved-Tip Stapler; 8mm SureForm 30 Stapler; 8mm SureForm 30 Reloads | NAY | 2024-09-10 |
| 289340 | 1487428215 | K241635 | da Vinci E-200 Electrosurgical Generator | GEI | 2024-08-05 |
| 231702 | 1487428215 | K241635 | da Vinci E-200 Electrosurgical Generator | GEI | 2024-08-05 |
| 125283 | 1487428215 | K241635 | da Vinci E-200 Electrosurgical Generator | GEI | 2024-08-05 |
| 231702 | 1756945401 | K241621 | Da Vinci Monopolar and Bipolar Adapters (378896) | GEI | 2024-08-02 |
| 125283 | 1756945401 | K241621 | Da Vinci Monopolar and Bipolar Adapters (378896) | GEI | 2024-08-02 |
| 231702 | 1558901073 | K241360 | Universal Seal (5-12 mm) | GCJ | 2024-08-05 |
| 125283 | 1558901073 | K241360 | Universal Seal (5-12 mm) | GCJ | 2024-08-05 |
| 125283 | 1904664680 | K241284 | da Vinci Surgical System (IS5000) | NAY | 2024-07-03 |
| 231702 | 1904664680 | K241284 | da Vinci Surgical System (IS5000) | NAY | 2024-07-03 |
| 289340 | 1904664680 | K241284 | da Vinci Surgical System (IS5000) | NAY | 2024-07-03 |
| 305563 | 1904664680 | K241284 | da Vinci Surgical System (IS5000) | NAY | 2024-07-03 |
| 231702 | 1931159164 | K240852 | da Vinci X Surgical System (IS4200); da Vinci Xi Surgical System (IS4000) | NAY | 2025-06-11 |
| 125283 | 1931159164 | K240852 | da Vinci X Surgical System (IS4200); da Vinci Xi Surgical System (IS4000) | NAY | 2025-06-11 |
| 305563 | 1163986702 | K240723 | da Vinci Xi Surgical System (IS4000); da Vinci X Surgical System (IS4200) | NAY | 2024-05-24 |
| 231702 | 1163986702 | K240723 | da Vinci Xi Surgical System (IS4000); da Vinci X Surgical System (IS4200) | NAY | 2024-05-24 |
| 125283 | 1163986702 | K240723 | da Vinci Xi Surgical System (IS4000); da Vinci X Surgical System (IS4200) | NAY | 2024-05-24 |
| 231702 | 2024995546 | K240502 | da Vinci SP Surgical System (SP1098) | NAY | 2024-07-08 |
| 125283 | 2024995546 | K240502 | da Vinci SP Surgical System (SP1098) | NAY | 2024-07-08 |
| 338411 | 1795948760 | K240135 | Ion Endoluminal System (Ion Fully Articulating Catheter) (IF1000) | EOQ | 2024-04-03 |
| 231702 | 1795948760 | K240135 | Ion Endoluminal System (Ion Fully Articulating Catheter) (IF1000) | EOQ | 2024-04-03 |
| 125283 | 1795948760 | K240135 | Ion Endoluminal System (Ion Fully Articulating Catheter) (IF1000) | EOQ | 2024-04-03 |
| 231702 | 2051080738 | K232984 | Ion Endoluminal System (IF1000) | EOQ | 2023-12-18 |
| 125283 | 2051080738 | K232984 | Ion Endoluminal System (IF1000) | EOQ | 2023-12-18 |
| 125283 | 1610792072 | K232773 | da Vinci SP Surgical System (SP1098) | NAY | 2024-06-04 |
| 231702 | 1610792072 | K232773 | da Vinci SP Surgical System (SP1098) | NAY | 2024-06-04 |
| 305563 | 2054031288 | K232610 | da Vinci Surgical System Model IS5000, da Vinci Insufflator and Tube Set with Smoke Evacuation | NAY | 2024-03-14 |
| 125283 | 2054031288 | K232610 | da Vinci Surgical System Model IS5000, da Vinci Insufflator and Tube Set with Smoke Evacuation | NAY | 2024-03-14 |
| 226106 | 2054031288 | K232610 | da Vinci Surgical System Model IS5000, da Vinci Insufflator and Tube Set with Smoke Evacuation | NAY | 2024-03-14 |
| 16862 | 2054031288 | K232610 | da Vinci Surgical System Model IS5000, da Vinci Insufflator and Tube Set with Smoke Evacuation | NAY | 2024-03-14 |
| 231702 | 2054031288 | K232610 | da Vinci Surgical System Model IS5000, da Vinci Insufflator and Tube Set with Smoke Evacuation | NAY | 2024-03-14 |
| 289340 | 2054031288 | K232610 | da Vinci Surgical System Model IS5000, da Vinci Insufflator and Tube Set with Smoke Evacuation | NAY | 2024-03-14 |
| 231702 | 1017624553 | K231798 | da Vinci SP Surgical System | NAY | 2023-11-08 |
| 125283 | 1017624553 | K231798 | da Vinci SP Surgical System | NAY | 2023-11-08 |
| 231702 | 1957822816 | K231358 | Universal Seal (5-12 mm) | GCJ | 2023-07-05 |
| 125283 | 1957822816 | K231358 | Universal Seal (5-12 mm) | GCJ | 2023-07-05 |
Product Codes Associated With Registrations
PMA
PMN
Da Vinci Fluorescence Imaging Vision System, Da Vinci Firefly Imaging System
Intuitive Surgical, Inc.
8 Mm SureForm 30 Curved-Tip Stapler, 8 Mm SureForm 30 Stapler, SureForm 30 Reloads
Intuitive Surgical, Inc.
Da Vinci SP Surgical System
Intuitive Surgical, Inc.
Ion Endoluminal System (Ion Fully Articulating Catheter), Ion Endoluminal System (Ion Peripheral Vision Probe)
Intuitive Surgical, Inc.
Da Vinci Xi Surgical System (IS4000), Da Vinci X Surgical System (IS4200)
Intuitive Surgical, Inc.
Da Vinci SP Surgical System (SP1098)
Intuitive Surgical, Inc.
Da Vinci SP Surgical System (SP1098)
Intuitive Surgical, Inc.
Da Vinci S/Si (IS2000/IS3000) 5mm And 8mm Reusable Instruments, Da Vinci Xi/X (IS4000/IS4200) 8mm Reusable Instruments
Intuitive Surgical, Inc.
Da Vinci SP Surgical System
Intuitive Surgical, Inc.
Da Vinci Xi Surgical System (IS4000), Da Vinci X Surgical System (IS4200)
Intuitive Surgical, Inc.
Ion Endoluminal System
Intuitive Surgical, Inc.
Ion Endoluminal System
Intuitive Surgical, Inc.
E-100 Electrosurgical Generator, SynchroSeal
Intuitive Surgical, Inc.
SureForm 45 Curved Tip, SureForm 45 Gray Reload
Intuitive Surgical, Inc.
Da Vinci Handheld Camera
Intuitive Surgical, Inc.
Da Vinci SP Surgical System, EndoWrist SP Instruments, And Accessories
Intuitive Surgical, Inc.
Endoscope Sterilization Tray
Intuitive Surgical, Inc.
Intuitive Surgical Vessel Sealer Extend
Intuitive Surgical, Inc.
Endoscope Sterilization Tray
Intuitive Surgical, Inc.
Applications
GUDID
Ion Tomosynthesis Board
INTUITIVE SURGICAL, INC.
None
INTUITIVE SURGICAL, INC.
None
INTUITIVE SURGICAL, INC.
da Vinci SP Endoscope, 0°
INTUITIVE SURGICAL, INC.
Da Vinci 8mm Assist Cannula
INTUITIVE SURGICAL, INC.
da Vinci 12mm Assist Cannula
INTUITIVE SURGICAL, INC.
da Vinci Energy
INTUITIVE SURGICAL, INC.
None
INTUITIVE SURGICAL, INC.
SureForm
INTUITIVE SURGICAL, INC.
SureForm
INTUITIVE SURGICAL, INC.
None
INTUITIVE SURGICAL, INC.
None
INTUITIVE SURGICAL, INC.
None
INTUITIVE SURGICAL, INC.
None
INTUITIVE SURGICAL, INC.
IRISEG
INTUITIVE SURGICAL, INC.
Force Feedback
INTUITIVE SURGICAL, INC.
Force Feedback
INTUITIVE SURGICAL, INC.
Force Feedback
INTUITIVE SURGICAL, INC.
Force Feedback
INTUITIVE SURGICAL, INC.
Force Feedback
INTUITIVE SURGICAL, INC.