BEUDAMED
    Product Code: NAY FDA class 2 21 CFR 876.1500

    System, Surgical, Computer Controlled Instrument

    Gastroenterology, Urology

    The Computer Controlled Surgical Instrument System is a robotic or computer-assisted surgical system used in urological, gastrointestinal, or other surgical procedures to enhance precision, dexterity, and control of surgical instruments through computer-mediated motion. If the device is reusable, validated reprocessing instructions must be included in the 510(k) submission. Classified as FDA Class 2, it requires 510(k) premarket clearance under regulation 876.1500 (Gastroenterology and Urology specialty, reviewed by the General Surgery panel).

    View on FDA
    510(k)s
    149
    FEI Numbers
    98
    Registration Numbers
    98
    Unique Applicants
    12
    Years Active
    25

    Basic Information

    Product Code
    NAY
    Device Class
    FDA class 2
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Review Panel
    SU
    Submission Type
    1

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    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).

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 149 510(k) clearances via K numbers.

    K Number Device Name
    K250674 Vessel Sealer Curved (480522)
    K240852 da Vinci X Surgical System (IS4200); da Vinci Xi Surgical System (IS4000)
    K250786 SP Endoscope, 0° (430600)
    K243714 da Vinci SP Surgical System (SP1098)
    K242427 da Vinci Xi Surgical System (IS4000); da Vinci X Surgical System (IS4200)
    K243582 da Vinci SP Advanced Access Port Kit (432701)
    K243641 da Vinci Surgical System (IS5000)
    K242318 da Vinci SP Surgical System (SP1098)
    K241814 da Vinci SP Instruments (SP1098)
    K241638 8mm SureForm 30 Curved-Tip Stapler; 8mm SureForm 30 Stapler; 8mm SureForm 30 Reloads
    K233866 Senhance Surgical System
    K240502 da Vinci SP Surgical System (SP1098)
    K241284 da Vinci Surgical System (IS5000)
    K232773 da Vinci SP Surgical System (SP1098)
    K240723 da Vinci Xi Surgical System (IS4000); da Vinci X Surgical System (IS4200)
    K232610 da Vinci Surgical System Model IS5000, da Vinci Insufflator and Tube Set with Smoke Evacuation
    K231798 da Vinci SP Surgical System
    K231224 da Vinci Xi Surgical System (IS4000), da Vinci X Surgical System (IS4200)
    K230033 Da Vinci SP Surgical System (SP1098)
    K223095 Senhance Surgical System
    K222839 EndoWrist Stapler 30 System, EndoWrist Stapler 45 System, SureForm 45 System, SureForm 60 System, 8 mm SureForm 30 System
    K223080 da Vinci X Surgical System (IS4200), da Vinci Xi Surgical System (IS4000)
    K222827 da Vinci Firefly Imaging System
    K214095 da Vinci X/Xi (IS4200/IS4000) 8mm Reusable Instruments
    K220889 Senhance Surgical System
    K213710 da Vinci Fluorescence Imaging Vision System, da Vinci Firefly Imaging System
    K220023 8mm Monopolar Curved Scissors
    K211997 8 mm SureForm 30 Curved-Tip Stapler, 8 mm SureForm 30 Stapler, SureForm 30 Reloads
    K212101 da Vinci SP Firefly Imaging System
    K212747 Da Vinci SP Surgical System
    K212054 Senhance Surgical System
    K211784 da Vinci Xi Surgical System (IS4000), da Vinci X Surgical System (IS4200)
    K211325 Senhance Surgical System
    K211316 da Vinci SP Surgical System (SP1098)
    K211595 da Vinci SP Surgical System (SP1098)
    K210918 da Vinci Fluorescence Imaging Vision System, da Vinci Firefly Imaging System
    K202166 Senhance Surgical System
    K203632 da Vinci S/Si (IS2000/IS3000) 5mm and 8mm Reusable Instruments, da Vinci Xi/X (IS4000/IS4200) 8mm Reusable Instruments
    K202968 Da Vinci SP Surgical System
    K200473 SoloAsisst II, Voice Control
    K202834 da Vinci Xi Surgical System (IS4000), da Vinci X Surgical System (IS4200)
    K202571 da Vinci SP Surgical System, Model SP1098, EndoWrist SP Instruments, and Accessories
    K192717 da Vinci SP Surgical System
    K192803 da Vinci Xi Surgical System, da Vinci X Surgical System
    K183086 da Vinci X and Xi Surgical System
    K200049 Senhance Surgical System
    K191529 da Vinci Xi Surgical System, da Vinci X Surgical System
    K192877 Senhance Surgical System
    K191280 E-100 Electrosurgical Generator, SynchroSeal
    K191736 da Vinci X/Xi 8mm Endoscope Plus, 0, da Vinci X/Xi 8mm Endoscope Plus, 30
    K190999 SureForm 45 Curved Tip, SureForm 45 Gray Reload
    K191482 Senhance Surgical System
    K182371 da Vinci SP Surgical System, EndoWrist SP Instruments, and Accessories
    K183224 SureForm 45, SureForm 45 Reloads
    K182421 Senhance Ultrasonic System
    K183107 Intuitive Surgical Vessel Sealer Extend
    K183098 Senhance Surgical System
    K182140 da Vinci Xi Surgical System, da Vinci X Surgical System
    K181517 Senhance Surgical System
    K171947 SOLOASSIST II
    K180351 EndoWrist Mercury Bipolar Grasper
    K173585 da Vinci Xi Surgical System, da Vinci X Surgical System
    K173721 SureForm 60 and SureForm 60 Reloads
    K173906 da Vinci SP Surgical System, EndoWrist SP Instruments, and Accessories
    K173415 EndoWrist 5mm Thoracic Grasper
    K180163 TransEnterix Senhance Surgical System
    K173337 Intuitive Surgical EndoWrist Vessel Sealer Extend
    K173842 da Vinci Xi Surgical System, da Vinci X Surgical System
    K180033 8mm Monopolar Curved Scissors
    K172643 da Vinci Xi Surgical System; da Vinci X Surgical System
    K171120 Senhance Surgical Robotic System
    K170879 IS4000 Stapler 45 Instrument and its Reusable Accessories, IS4000 EndoWrist Stapler 30 Instrument, IS3000 Stapler 45 Instrument and its Reusable Accessories
    K170641 da Vinci S/Si Endoscopes, da Vinci Xi Endoscopes
    K171632 da Vinci Xi Surgical System
    K170875 da Vinci Si Single-Site Instruments and Accessories, da Vinci Xi Single-Site Instruments and Accessories
    K170645 da Vinci Xi EndoWrist Instruments and Accessories
    K170644 da Vinci S/Si EndoWrist Instruments and Accessories, Harmonic ACE Curved Shears (5mm & 8mm)
    K171699 da Vinci Xi Surgical System, da Vinci Si Surgical System, da Vinci X Surgical System
    K171426 da Vinci Xi 8mm Endoscope, 0 degree, da Vinci Xi 8mm Endoscope, 30 degree
    K170713 da Vinci Xi Surgical System
    K171388 EndoWrist Stapler 45 System and Stapler 45 Reloads
    K171294 da Vinci X Surgical System
    K170865 EndoWrist Vessel Sealer, 8 mm Harmonic ACE Curved Shears, da Vinci Single-Site Instruments and Accessories
    K170508 EndoWrist Stapler 45 Instrument, EndoWrist Stapler 45 Reloads, EndoWrist Stapler 30 Instrument, EndoWrist Stapler 30 Reloads
    K162973 EndoWrist Suction Irrigator
    K161178 da Vinci Xi Surgical System
    K162411 da Vinci Xi 12 – 8 mm Reducer
    K153276 da Vinci Xi Surgical System
    K161271 da Vinci Xi Surgical System
    K152892 da Vinci Xi Surgical System
    K152578 da Vinci Surgical System, Model IS4000
    K152448 da Vinci Single-Site Instrument and Accessories
    K152421 IS4000 Stapler 30 Instrument and Stapler 30 Reloads
    K151794 da Vinci Xi Surgical System
    K150284 IS4000 da Vinci EndoWrist Instruments
    K150837 IS4000 Small Clip Applier, IS4000 Long Bipolar Forceps
    K143132 IS4000 8mm Harmonic ACE Curved Shears
    K142683 12 mm Endoscopes and Accessories
    K143217 12 mm & Stapler Bladeless Obturators
    K141075 SINGLE-SITE WRISTED NEEDLE DRIVER
    K123329 DA VINVI SURGICAL SYSTEM
    K141077 DA VINCI FIREFLY IMAGING SYSTEM
    K140553 ENDOWRIST STAPLER 45 AND STAPLER 45 RELOADS
    K140189 ENDOWRIST VESSEL SEALER
    K131962 DA VINCI SP SURGICAL SYSTEM, ENDOWRIST SP INSTRUMENTS, AND ACCESSORIES
    K131861 DA VINCI SURGICAL SYSTEM, ENDOWRIST INSTRUMENTS AND ACCESSORIES
    K130266 ENDOWRIST ONE VESSEL SEALER
    K122532 DA VINCI SINGLE-SITE INSTRUMENTS AND ACCESSORIES
    K130726 DA VINCI SINGLE-SITE PERMANENT CAUTERY HOOK
    K123840 CONNECT FOR DA VINCI SURGICAL SYSTEM(S)
    K123463 INTUITIVE SURGICAL DA VINCI SI SURGICAL SYSTEM SMARTPEDALS
    K121921 INTUITIVE SURGICAL ONSITE FOR DA VINCI SURGICAL SYSTEMS
    K113706 ENDOWRIST STAPLER SYSTEM
    K120215 SINGLE-SITE MEDIUM-LARGE CLIP APPLIER, SINGLE-SITE CADIERE GRASPER, SINGLE-SITE FUNDUS GRASPER, SINGLE-SITE CROCODILE
    K110639 ENDOWRIST ONE VESSEL SEALER
    K112208 INTUTIVE SURGICAL DA VINCI SINGLE SITE INSTRUMENTS AND ACCESSORIES
    K112263 MONOPOLAR CURVED SCISSORS TIP COVER ACCESSORY
    K112584 5MM/8MM HARMONIC ACE(TM) CURVED SHEARS, DISPOSABLE HARMONIC ACE(TM) INSERT, DISPOSABLE HARMONIC(TM) CURVED SHEARS INSERT
    K110451 ENDOWRIST ONE SUCTION/IRRIGATOR
    K101581 INTUITIVE SURGICAL DA VINCI S SURGICAL SYSTEM WITH DA VINCI CONNECT & DA VINCI ONSITE, MODEL IS2000
    K101743 5MM FLARED CANNULA MODEL 420262, 8MM FLARED CANNULA MODEL 420319
    K093217 5 MM HARMONIC ACE INSTRUMENT (USED WITH DA VINCI IS1200 & IS2000/IS3000 SYSTEM)
    K090993 INTUITIVE SURGICAL ENDOSCOPIC INSTRUMENT CONTROL SYSTEMS, MODELS IS1200, IS2000 AND IS3000
    K082497 INTUITIVE SURGICAL ENDOWRIST ONE HOT SHEARS INSTRUMENT
    K081137 INTUITIVE SURGICAL DA VINCI SI SURGICAL SYSTEM: MODEL IS3000
    K081207 INTUITIVE SURGICAL DA VINCI S SURGICAL SYSTEM, MODEL IS2000, WITH DA VINCI CONNECT AND ONSITE
    K080291 INTUITIVE SURGICAL DA VINCI ENDOSCOPIC INSTRUMENTS AND CONTROL SYSTEM AND ENDOWRIST STABILIZER
    K070947 INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM AND ENDOSCOPIC INSTRUMENTS AND ENDOWRIST CARDIAC PROBE GRASPER
    K072627 INTUITIVE SURGICAL DA VINCI AND DA VINCI S SURGICAL SYSTEM AND ENDOSCOPIC INSTRUMENTS AND ENDOWRIST INTRODUCER
    K063220 DA VINCI S SURGICAL SYSTEM-V1.1, MODEL IS2000
    K061260 INTUITIVE SURGICAL ENDOWRIST PK DISSECTING FORCEPS, MODELS 400214 & 420214
    K060391 INTUITIVE SURGICAL ENDOWRIST STABILIZER, MODEL 420182
    K050802 MODIFICATION TO INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM AND ENDOSCOPIC INSTRUMENTS
    K050369 INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM, MODEL IS2000
    K043288 MODIFICATION TO INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM AND ENDOSCOPIC INSTRUMENTS
    K050005 INTUITIVE SURGICAL MONOPOLAR CURVED SCISSORS, MODEL 400179; TIP COVER ACCESSORY, MODEL 400180
    K043153 INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM AND ENDOSCOPIC INSTRUMENTS, MODELS IS1200 & IS1000
    K042855 INTUITIVE SURGICAL HARMONIC CURVED SHEARS INSTRUMENT
    K040237 INTUITIVE SURGICAL DA VINCI ENDOSCOPIC INSTRUMENT CONTROL SYSTEM AND ENDOSCOPIC INSTRUMENTS
    K040948 INTUITIVE SURGICAL ENDOPASS ENDOSCOPIC DELIVERY INSTRUMENT, MODEL P/N 400170
    K030578 BIPOLAR GRASPER AND BIPOLAR SCISSORS FOR THE ZEUS MICROWRIST SURGICAL SYSTEM
    K022574 INTUITIVE SURGICAL ENDOSCOPIC INSTRUMENT CONTROL SYSTEM & ENDOSCOPIC INSTRUMENTS, MODEL DA VINCI ISI 1000/1200
    K021152 ZEUS MICROWRIST ROBOTIC SURGICAL SYSTEM AND ACCESSORIES
    K021036 INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM, MODEL IS1000
    K012833 INTUITIVE SURGICAL BIPOLAR FORCEPS
    K011281 INTUITIVE SURGICAL ULTRASONIC SHEARS
    K011002 INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM, MODEL ISI 1000
    K002489 INTUITIVE SURGICAL DA VINCI ENDOSCOPIC CONTROL SYSTEM
    K990144 INTUITIVE SURGICAL ENDOSCOPIC INSTRUMENTS, INTUITIVE SURGICAL ENDOSCOPIC INSTRUMENT CONTROL SYSTEM

    FEI Numbers

    This FDA classification entry is associated with 98 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 98 registration numbers. Click on an entry to view related FDA registrations.