Intuitive Surgical, Inc.
Intuitive Surgical, Inc. holds FDA 510(k) medical device clearances, first cleared 1997, most recent 2026, with 256 FDA device recalls on record.
Clearances by Intuitive Surgical, Inc. — page 2
101–182 of 182- 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
- 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
- K151450 — Endoscope Sterilization Tray
- K153126 — da Vinci Xi Hasson Cone
- K152663 — Bladeless Optical Obturators
- K150284 — IS4000 da Vinci EndoWrist Instruments
- K150837 — IS4000 Small Clip Applier, IS4000 Long Bipolar Forceps
- K143132 — IS4000 8mm Harmonic ACE Curved Shears
- K142937 — Endoscope Sterilization Tray
- K142683 — 12 mm Endoscopes and Accessories
- K143217 — 12 mm & Stapler Bladeless Obturators
- K123329 — DA VINVI SURGICAL SYSTEM
- K141077 — DA VINCI FIREFLY IMAGING SYSTEM
- K140553 — ENDOWRIST STAPLER 45 AND STAPLER 45 RELOADS
- K140189 — ENDOWRIST VESSEL SEALER
- K133203 — SINGLE-SITE PORT
- K131962 — DA VINCI SP SURGICAL SYSTEM, ENDOWRIST SP INSTRUMENTS, AND ACCESSORIES
- K131861 — DA VINCI SURGICAL SYSTEM, ENDOWRIST INSTRUMENTS AND ACCESSORIES
- K133167 — MONOPOLAR CAUTERY CORD, BIPOLAR CAUTERY CORD
- K124031 — DA VINCI FLUORESCENCE IMAGING VISION SYSTEM
- 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
- K101077 — DA VINCI FLUORESCENCE IMAGING VISION SYSTEM, MODEL FF 100
- 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
- K073112 — DA VINCI SONICPRO CLEANING SYSTEM, MODEL 400253
- K080291 — INTUITIVE SURGICAL DA VINCI ENDOSCOPIC INSTRUMENTS AND CONTROL SYSTEM AND ENDOWRIST STABILIZER
- K080155 — MODIFICATION TO:INTUITIVE SURGICAL STEREO VIEW ENDOSCOPIC SYSTEM
- K072211 — INTUITIVE SURGICAL INSTRUMENT AND ACCESSORIES STERILIZATION TRAYS
- 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
- K071405 — PROBE HOLDER SYSTEM
- 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
- K050404 — INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM AND ENDOSCOPIC INSTRUMENTS
- 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
- K022574 — INTUITIVE SURGICAL ENDOSCOPIC INSTRUMENT CONTROL SYSTEM & ENDOSCOPIC INSTRUMENTS, MODEL DA VINCI ISI 1000/1200
- K021036 — INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM, MODEL IS1000
- K013952 — INTUITIVE SURGICAL STERO VIEW ENDOSCOPIC SYSTEM
- K013416 — INTUITIVE SURGICAL ENDOWRIST ENDOSCOPIC INSTRUMENT FAMILY
- 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
- K001666 — MODIFICATION TO INTUITIVE SURGICAL STEREO VIEW ENDOSCOPIC SYSTEM
- K990144 — INTUITIVE SURGICAL ENDOSCOPIC INSTRUMENTS, INTUITIVE SURGICAL ENDOSCOPIC INSTRUMENT CONTROL SYSTEM
- K990188 — INTUITIVE SURGICAL STEREO VIEW ENDOSCOPIC SYSTEM, MODEL SVS-1
- K965001 — INTUITIVE SURGICAL MONARCH LAPAROSCOPIC MANIPULATOR
Data sourced from openFDA. This site is unofficial and independent of the FDA.