Atlas FDA

NAY

165 FDA 510(k) clearances · Product code

112 daysmedian time to decision
268 days90th percentile
165clearances measured

FDA profile

Official device name
System, Surgical, Computer Controlled Instrument
Device class
Class II (moderate risk)
Regulation
21 CFR 876.1500
Medical specialty
Gastroenterology, Urology
FDA definition
If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
Adverse events (MAUDE)
2021: 1,997 · 2022: 5,727 · 2023: 10,898 · 2024: 12,872 · 2025: 49,306 · 2026: 33,446
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
da Vinci Surgical System, Model IS5000 (K261824)Intuitive Surgical, Inc.2026-07-31
da Vinci Firefly Imaging System (K260695)Intuitive Surgical2026-05-22
Senhance Ultrasonic System (K254192)Asensus Surgical2026-05-12
da Vinci Force Feedback Instruments (K253986)Intuitive Surgical, Inc.2026-03-11
da Vinci Surgical System (IS5000) (K251739)Intuitive Surgical, Inc.2026-01-16
da Vinci SP Surgical System (SP1098); da Vinci E-200 Generator (K253556)Intuitive Surgical, Inc.2026-01-16
da Vinci SP Surgical System (SP1098) (K252675)Intuitive Surgical, Inc.2025-12-15
da Vinci SP Surgical System (SP1098) (K252069)Intuitive Surgical, Inc.2025-12-02
da Vinci SP Surgical System (SP1098) (K251426)Intuitive Surgical, Inc.2025-10-03
da Vinci SP Surgical System (SP1098) (K251817)Intuitive Surgical, Inc.2025-09-10
da Vinci Surgical System (IS5000) (K251227)Intuitive Surgical, Inc.2025-09-08
da Vinci SP Surgical System (SP1098) (K251324)Intuitive Surgical, Inc.2025-08-29
da Vinci SP Firefly Imaging System (K252350)Intuitive Surgical, Inc.2025-08-28
da Vinci Surgical System, IS5000 (K250442)Intuitive Surgical, Inc.2025-07-29
Da Vinci Surgical System (IS5000) (K251213)Intuitive Surgical, Inc.2025-07-23
da Vinci Surgical System (IS5000) (K251202)Intuitive Surgical, Inc.2025-07-16
Vessel Sealer Curved (480522) (K250674)Intuitive Surgical, Inc.2025-06-13
da Vinci X Surgical System (IS4200); da Vinci Xi Surgical System (IS4000) (K240852)Intuitive Surgical, Inc.2025-06-11
SP Endoscope, 0° (430600) (K250786)Intuitive Surgical, Inc.2025-05-13
da Vinci SP Surgical System (SP1098) (K243714)Intuitive Surgical, Inc.2025-04-24
da Vinci Xi Surgical System (IS4000); da Vinci X Surgical System (IS4200) (K242427)Intuitive Surgical, Inc.2025-04-01
da Vinci SP Advanced Access Port Kit (432701) (K243582)Intuitive Surgical, Inc.2025-02-28
da Vinci Surgical System (IS5000) (K243641)Intuitive Surgical, Inc.2024-12-16
da Vinci SP Surgical System (SP1098) (K242318)Intuitive Surgical, Inc.2024-11-26
da Vinci SP Instruments (SP1098) (K241814)Intuitive Surgical, Inc.2024-11-18
8mm SureForm 30 Curved-Tip Stapler; 8mm SureForm 30 Stapler; 8mm SureForm 30 Reloads (K241638)Intuitive Surgical, Inc.2024-09-10
Senhance Surgical System (K233866)Asensus Surgical, Inc.2024-07-19
da Vinci SP Surgical System (SP1098) (K240502)Intuitive Surgical, Inc.2024-07-08
da Vinci Surgical System (IS5000) (K241284)Intuitive Surgical, Inc.2024-07-03
da Vinci SP Surgical System (SP1098) (K232773)Intuitive Surgical, Inc.2024-06-04
da Vinci Xi Surgical System (IS4000); da Vinci X Surgical System (IS4200) (K240723)Intuitive Surgical2024-05-24
da Vinci Surgical System Model IS5000, da Vinci Insufflator and Tube Set with Smoke Evacuation (K232610)Intuitive Surgical, Inc.2024-03-14
da Vinci SP Surgical System (K231798)Intuitive Surgical, Inc.2023-11-08
da Vinci Xi Surgical System (IS4000), da Vinci X Surgical System (IS4200) (K231224)Intuitive Surgical, Inc.2023-05-12
Da Vinci SP Surgical System (SP1098) (K230033)Intuitive Surgical, Inc.2023-04-05
Senhance Surgical System (K223095)Asensus Surgical, Inc.2023-03-16
EndoWrist Stapler 30 System, EndoWrist Stapler 45 System, SureForm 45 System, SureForm 60 System, 8 mm SureForm 30 System (K222839)Intuitive Surgical, Inc.2023-03-16
da Vinci X Surgical System (IS4200), da Vinci Xi Surgical System (IS4000) (K223080)Intuitive Surgical, Inc.2022-11-22
da Vinci Firefly Imaging System (K222827)Intuitive Surgical, Inc.2022-10-20
da Vinci X/Xi (IS4200/IS4000) 8mm Reusable Instruments (K214095)Intuitive Surgical, Inc.2022-08-15
Senhance Surgical System (K220889)Asensus Surgical, Inc.2022-05-27
da Vinci Fluorescence Imaging Vision System, da Vinci Firefly Imaging System (K213710)Intuitive Surgical, Inc.2022-02-17
8mm Monopolar Curved Scissors (K220023)Intuitive Surgical, Inc.2022-01-31
8 mm SureForm 30 Curved-Tip Stapler, 8 mm SureForm 30 Stapler, SureForm 30 Reloads (K211997)Intuitive Surgical, Inc.2021-12-10
da Vinci SP Firefly Imaging System (K212101)Intuitive Surgical, Inc.2021-11-23
Da Vinci SP Surgical System (K212747)Intuitive Surgical, Inc.2021-09-29
Senhance Surgical System (K212054)Asensus Surgical, Inc.2021-08-30
da Vinci Xi Surgical System (IS4000), da Vinci X Surgical System (IS4200) (K211784)Intuitive Surgical, Inc.2021-08-06
Senhance Surgical System (K211325)Asensus Surgical, Inc.2021-07-27
da Vinci SP Surgical System (SP1098) (K211316)Intuitive Surgical, Inc.2021-07-23
da Vinci SP Surgical System (SP1098) (K211595)Intuitive Surgical, Inc.2021-06-23
da Vinci Fluorescence Imaging Vision System, da Vinci Firefly Imaging System (K210918)Intuitive Surgical, Inc.2021-04-26
Senhance Surgical System (K202166)Transenterix, Inc.2021-03-02
da Vinci S/Si (IS2000/IS3000) 5mm and 8mm Reusable Instruments, da Vinci Xi/X (IS4000/IS4200) 8mm Reusable Instruments (K203632)Intuitive Surgical, Inc.2021-02-10
SoloAsisst II, Voice Control (K200473)Aktormed GmbH2020-12-22
Da Vinci SP Surgical System (K202968)Intuitive Surgical, Inc.2020-12-22
da Vinci Xi Surgical System (IS4000), da Vinci X Surgical System (IS4200) (K202834)Intuitive Surgical, Inc.2020-12-10
da Vinci SP Surgical System, Model SP1098, EndoWrist SP Instruments, and Accessories (K202571)Intuitive Surgical, Inc.2020-11-12
da Vinci SP Surgical System (K192717)Intuitive Surgical, Inc.2020-09-28
da Vinci Xi Surgical System, da Vinci X Surgical System (K192803)Intuitive Surgical2020-04-29
da Vinci X and Xi Surgical System (K183086)Intuitive Surgical, Inc.2020-03-31
Senhance Surgical System (K200049)Transenterix, Inc.2020-03-09
da Vinci Xi Surgical System, da Vinci X Surgical System (K191529)Intuitive Surgical2020-02-06
Senhance Surgical System (K192877)Transenterix, Inc.2019-11-22
E-100 Electrosurgical Generator, SynchroSeal (K191280)Intuitive Surgical, Inc.2019-11-14
da Vinci X/Xi 8mm Endoscope Plus, 0, da Vinci X/Xi 8mm Endoscope Plus, 30 (K191736)Intuitive Surgical2019-07-26
SureForm 45 Curved Tip, SureForm 45 Gray Reload (K190999)Intuitive Surgical, Inc.2019-07-12
Senhance Surgical System (K191482)Transenterix, Inc.2019-07-11
da Vinci SP Surgical System, EndoWrist SP Instruments, and Accessories (K182371)Intuitive Surgical, Inc.2019-03-14
SureForm 45, SureForm 45 Reloads (K183224)Intuitive Surgical2019-01-18
Senhance Ultrasonic System (K182421)Transenterix, Inc.2019-01-11
Intuitive Surgical Vessel Sealer Extend (K183107)Intuitive Surgical, Inc.2018-12-11
Senhance Surgical System (K183098)Transenterix, Inc.2018-12-06
da Vinci Xi Surgical System, da Vinci X Surgical System (K182140)Intuitive Surgical, Inc.2018-10-24
Senhance Surgical System (K181517)Transenterix, Inc.2018-10-09
SOLOASSIST II (K171947)Aktormed GmbH2018-09-21
EndoWrist Mercury Bipolar Grasper (K180351)Intuitive Surgical, Inc.2018-08-07
da Vinci Xi Surgical System, da Vinci X Surgical System (K173585)Intuitive Surgical, Inc.2018-07-19
SureForm 60 and SureForm 60 Reloads (K173721)Intuitive Surgical2018-07-05
da Vinci SP Surgical System, EndoWrist SP Instruments, and Accessories (K173906)Intuitive Surgical, Inc.2018-05-31
EndoWrist 5mm Thoracic Grasper (K173415)Intuitive Surgical, Inc.2018-05-31
TransEnterix Senhance Surgical System (K180163)Transenterix, Inc.2018-05-25
Intuitive Surgical EndoWrist Vessel Sealer Extend (K173337)Intuitive Surgical, Inc.2018-04-26
da Vinci Xi Surgical System, da Vinci X Surgical System (K173842)Intuitive Surgical, Inc.2018-04-23
8mm Monopolar Curved Scissors (K180033)Intuitive Surgical, Inc.2018-04-06
da Vinci Xi Surgical System; da Vinci X Surgical System (K172643)Intuitive Surgical, Inc.2018-01-31
Senhance Surgical Robotic System (K171120)Transenterix, Inc.2017-10-13
IS4000 Stapler 45 Instrument and its Reusable Accessories, IS4000 EndoWrist Stapler 30 Instrument, IS3000 Stapler 45 Instrument and its Reusable Accessories (K170879)Intuitive Surgical, Inc.2017-09-21
da Vinci S/Si Endoscopes, da Vinci Xi Endoscopes (K170641)Intuitive Surgical, Inc.2017-09-21
da Vinci Xi Surgical System (K171632)Intuitive Surgical, Inc.2017-09-19
da Vinci Si Single-Site Instruments and Accessories, da Vinci Xi Single-Site Instruments and Accessories (K170875)Intuitive Surgical, Inc.2017-09-12
da Vinci Xi EndoWrist Instruments and Accessories (K170645)Intuitive Surgical, Inc.2017-09-11
da Vinci S/Si EndoWrist Instruments and Accessories, Harmonic ACE Curved Shears (5mm & 8mm) (K170644)Intuitive Surgical, Inc.2017-09-11
da Vinci Xi Surgical System, da Vinci Si Surgical System, da Vinci X Surgical System (K171699)Intuitive Surgical, Inc.2017-07-28
da Vinci Xi 8mm Endoscope, 0 degree, da Vinci Xi 8mm Endoscope, 30 degree (K171426)Intuitive Surgical, Inc.2017-06-13
da Vinci Xi Surgical System (K170713)Intuitive Surgical, Inc.2017-06-13
EndoWrist Stapler 45 System and Stapler 45 Reloads (K171388)Intuitive Surgical, Inc.2017-05-31
da Vinci X Surgical System (K171294)Intuitive Surgical, Inc.2017-05-26
EndoWrist Vessel Sealer, 8 mm Harmonic ACE Curved Shears, da Vinci Single-Site Instruments and Accessories (K170865)Intuitive Surgical, Inc.2017-04-21
EndoWrist Stapler 45 Instrument, EndoWrist Stapler 45 Reloads, EndoWrist Stapler 30 Instrument, EndoWrist Stapler 30 Reloads (K170508)Intuitive Surgical, Inc.2017-03-10
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