ClearanceBrief
Company · US

Intuitive Surgical, Inc.

FDA 510(k) clearances and medical device recalls filed under this name, 1997 to 2026. Name variants (Inc, Corp, punctuation) are merged.

198510(k) clearances (13 in 12 months)
277recalls (17 in 12 months)
273recalls that name a 510(k)

Product codes

CodeDeviceRecords
NAYSystem, Surgical, Computer Controlled Instrument393
GCJLaparoscope, General & Plastic Surgery20
EOQBronchoscope (Flexible Or Rigid)17
KKXDrape, Surgical, Antimicrobial14
KCTSterilization Wrap Containers, Trays, Cassettes & Other Accessories9
GEIElectrosurgical, Cutting & Coagulation & Accessories7
GAGStapler, Surgical3
GDWStaple, Implantable2
QIHAutomated Radiological Image Processing Software2
FDSGastroscope And Accessories, Flexible/Rigid1
GCYApparatus, Suction, Single Patient Use, Portable, Nonpowered1
HETLaparoscope, Gynecologic (And Accessories)1
LKFCannula, Manipulator/Injector, Uterine1
LLZSystem, Image Processing, Radiological1
LRWScissors, General, Surgical1
NVEWasher, Cleaner, Automated, Endoscope1
OWNConfocal Optical Imaging1

Latest 510(k) clearances

Decided510(k)Device and applicantCode
Oct 14, 2026K262455da Vinci 5 Handheld Camera Head (470080);da Vinci 5 Handheld Camera Laparoscope, 0 degree (470081);da Vinci 5 Handheld C
Intuitive Surgical, Inc.
GCJ
Sep 8, 2026K261823da Vinci Surgical System, Model IS5000
Intuitive Surgical, Inc.
NAY
Aug 7, 2026K253702Intuitive Endoluminal Gastrointestinal System (IG1000)
Intuitive Surgical, Inc.
FDS
Jul 31, 2026K261824da Vinci Surgical System, Model IS5000
Intuitive Surgical, Inc.
NAY
Jul 14, 2026K261249Universal Seal (5-12 mm)
Intuitive Surgical, Inc.
GCJ
May 22, 2026K260695da Vinci Firefly Imaging System
Intuitive Surgical
NAY
Mar 11, 2026K253986da Vinci Force Feedback Instruments
Intuitive Surgical, Inc.
NAY
Feb 24, 2026K253978Universal Seal (5-12 mm)
Intuitive Surgical, Inc.
GCJ
Jan 16, 2026K253556da Vinci SP Surgical System (SP1098); da Vinci E-200 Generator
Intuitive Surgical, Inc.
NAY
Jan 16, 2026K251739da Vinci Surgical System (IS5000)
Intuitive Surgical, Inc.
NAY
Dec 16, 2025K251763IRISeg
Intuitive Surgical, Inc.
QIH
Dec 15, 2025K252675da Vinci SP Surgical System (SP1098)
Intuitive Surgical, Inc.
NAY
Dec 2, 2025K252069da Vinci SP Surgical System (SP1098)
Intuitive Surgical, Inc.
NAY
Oct 3, 2025K251426da Vinci SP Surgical System (SP1098)
Intuitive Surgical, Inc.
NAY
Sep 23, 2025K252045Ion Endoluminal System (IF1000)
Intuitive Surgical, Inc.
EOQ
Sep 10, 2025K251817da Vinci SP Surgical System (SP1098)
Intuitive Surgical, Inc.
NAY
Sep 8, 2025K251227da Vinci Surgical System (IS5000)
Intuitive Surgical, Inc.
NAY
Sep 5, 2025K252528Ion Endoluminal System (IF1000)
Intuitive Surgical, Inc.
EOQ
Aug 29, 2025K251324da Vinci SP Surgical System (SP1098)
Intuitive Surgical, Inc.
NAY
Aug 28, 2025K252350da Vinci SP Firefly Imaging System
Intuitive Surgical, Inc.
NAY
Jul 29, 2025K250442da Vinci Surgical System, IS5000
Intuitive Surgical, Inc.
NAY
Jul 23, 2025K251213Da Vinci Surgical System (IS5000)
Intuitive Surgical, Inc.
NAY
Jul 16, 2025K251202da Vinci Surgical System (IS5000)
Intuitive Surgical, Inc.
NAY
Jul 2, 2025K2514908 mm Assist Cannula; 12 mm Assist Cannula
Intuitive Surgical, Inc.
GCJ
Jun 13, 2025K250674Vessel Sealer Curved (480522)
Intuitive Surgical, Inc.
NAY
Jun 11, 2025K240852da Vinci X Surgical System (IS4200); da Vinci Xi Surgical System (IS4000)
Intuitive Surgical, Inc.
NAY
May 13, 2025K250786SP Endoscope, 0° (430600)
Intuitive Surgical, Inc.
NAY
Apr 24, 2025K243714da Vinci SP Surgical System (SP1098)
Intuitive Surgical, Inc.
NAY
Apr 1, 2025K242427da Vinci Xi Surgical System (IS4000); da Vinci X Surgical System (IS4200)
Intuitive Surgical, Inc.
NAY
Mar 10, 2025K243596da Vinci SP SureForm 45 Staplers and Reloads (SP1098)
Intuitive Surgical, Inc.
GAG
Feb 28, 2025K243582da Vinci SP Advanced Access Port Kit (432701)
Intuitive Surgical, Inc.
NAY
Dec 16, 2024K243641da Vinci Surgical System (IS5000)
Intuitive Surgical, Inc.
NAY
Dec 10, 2024K242461IRISeg
Intuitive Surgical, Inc.
QIH
Nov 26, 2024K242318da Vinci SP Surgical System (SP1098)
Intuitive Surgical, Inc.
NAY
Nov 18, 2024K241814da Vinci SP Instruments (SP1098)
Intuitive Surgical, Inc.
NAY
Sep 24, 2024K242070Ion Endoluminal System (IF 1000)
Intuitive Surgical, Inc.
EOQ
Sep 10, 2024K2416388mm SureForm 30 Curved-Tip Stapler; 8mm SureForm 30 Stapler; 8mm SureForm 30 Reloads
Intuitive Surgical, Inc.
NAY
Aug 5, 2024K241635da Vinci E-200 Electrosurgical Generator
Intuitive Surgical
GEI
Aug 5, 2024K241360Universal Seal (5-12 mm)
Intuitive Surgical, Inc.
GCJ
Aug 2, 2024K241621Da Vinci Monopolar and Bipolar Adapters (378896)
Intuitive Surgical
GEI
Jul 8, 2024K240502da Vinci SP Surgical System (SP1098)
Intuitive Surgical, Inc.
NAY
Jul 3, 2024K241284da Vinci Surgical System (IS5000)
Intuitive Surgical, Inc.
NAY
Jun 4, 2024K232773da Vinci SP Surgical System (SP1098)
Intuitive Surgical, Inc.
NAY
May 24, 2024K240723da Vinci Xi Surgical System (IS4000); da Vinci X Surgical System (IS4200)
Intuitive Surgical
NAY
Apr 3, 2024K240135Ion™ Endoluminal System (Ion™ Fully Articulating Catheter) (IF1000)
Intuitive Surgical, Inc.
EOQ
Mar 14, 2024K232610da Vinci Surgical System Model IS5000, da Vinci Insufflator and Tube Set with Smoke Evacuation
Intuitive Surgical, Inc.
NAY
Dec 18, 2023K232984Ion Endoluminal System (IF1000)
Intuitive Surgical, Inc.
EOQ
Nov 8, 2023K231798da Vinci SP Surgical System
Intuitive Surgical, Inc.
NAY
Jul 5, 2023K231358Universal Seal (5-12 mm)
Intuitive Surgical, Inc.
GCJ
Jun 21, 2023K231212da Vinci E-200 Electrosurgical Generator
Intuitive Surgical
GEI

Newest 50 of 198.

Latest recalls

DateFirm and productCodeLinked 510(k)
Jul 10, 2026Intuitive Surgical, Inc.
da Vinci SP Instrument Arm Drape, SP, 1-PACK, Part Number: 430013-13, 430013-15
Open, Classified		 NAYK173906
K182371
Jun 22, 2026Intuitive Surgical, Inc.
Da Vinci ASSY, PSS, SP1098, Part Number: 380601
Open, Classified		 NAYK173906
K182371
Jun 4, 2026Intuitive Surgical, Inc.
Brand Name: Da Vinci 5 Product Name: ASSY,DV5 TOWER,IS5000 Model/Catalog Number: 380746 Software Version: N/A Product Description: Preface: This report under 21 CFR 806.10 is being submitted for the
Open, Classified		 NAYK232610
May 1, 2026Intuitive Surgical, Inc.
Brand Name: Da Vinci X and Da Vinci Xi Product Name: da Vinci X, Xi Surgical System Model/Catalog Number: IS4000; IS4200 Software Version: N/A Product Description: he da Vinci Xi, X Surgical systems
Open, Classified		 NAYK131861
K171294
May 1, 2026Intuitive Surgical, Inc.
Intuitive 8 mm SureForm 30 Gray Reloads Reference Numbers: 48230M-05 and 48230M-06
Open, Classified		 NAYK211997
K222839 +1
Mar 30, 2026Intuitive Surgical, Inc.
Brand Name: da Vinci S, Si Permanent Cautery Hook Instrument Product Name: da Vinci S, Si Permanent Cautery Hook Instrument Model/Catalog Number: 420183 Software Version: NA Product Description: EndoW
Open, Classified		 NAYK050369
Mar 30, 2026Intuitive Surgical, Inc.
Brand Name: da Vinci S, Si Tenaculum Forceps Instrument Product Name: da Vinci S, Si Tenaculum Forceps Instrument Model/Catalog Number: 420207 Software Version: N/A Product Description: EndoWrist Inst
Open, Classified		 NAYK050369
Mar 30, 2026Intuitive Surgical, Inc.
Brand Name: da Vinci S, Si Grasping Retractor Instrument Product Name: da Vinci S, Si Grasping Retractor Instrument Model/Catalog Number: 420278 Software Version: NA Product Description: EndoWrist Ins
Open, Classified		 NAYK050369
Mar 30, 2026Intuitive Surgical, Inc.
Brand Name: da Vinci S, Si Mega Needle Driver Instrument Product Name: da Vinci S, Si Mega Needle Driver Instrument Model/Catalog Number: 420194 Software Version: NA Product Description: EndoWrist Ins
Open, Classified		 NAYK050369
Mar 30, 2026Intuitive Surgical, Inc.
Brand Name: da Vinci S, Si Double Fenestrated Grasper Instrument Product Name: da Vinci S, Si Double Fenestrated Grasper Instrument Model/Catalog Number: 420189 Software Version: NA Product Descriptio
Open, Classified		 NAYK050369
Mar 30, 2026Intuitive Surgical, Inc.
Brand Name: da Vinci S, Si Monopolar Curved Scissors Instrument Product Name: da Vinci S and Si Monopolar Curved Scissors Instrument Model/Catalog Number: 420179 Software Version: N/A Product Descript
Open, Classified		 NAYK050369
K180033
Feb 18, 2026Intuitive Surgical, Inc.
Da Vinci 5 ASSY, DV5 CONSOLE, IS5000 Model/Catalog Number: 380730 Used for minimally invasive surgery.
Open, Classified		 NAYK232610
Feb 12, 2026Intuitive Surgical, Inc.
da Vinci 5 Surgeon Console Viewer Display, ASSY, DV5 CONSOLE, IS5000, Part Number: 380730-45
Open, Classified		 NAYK232610
Feb 2, 2026Intuitive Surgical, Inc.
Brand Name: Da Vinci Product Name: da Vinci X, Xi Surgical System, & da Vinci 5 Surgical System Model/Catalog Number: IS4000; IS4200; IS5000 Software Version: N/A Product Description: The da Vinci Xi
Open, Classified		 NAYK131861
K171294 +1
Jan 21, 2026Intuitive Surgical, Inc.
Brand Name: Ion Endoluminal System Product Name: Ion Vision Probe Bag Model/Catalog Number: 490127 Software Version: N/A Product Description: The Ion Endoluminal System is a robotically assisted platf
Open, Classified		 EOQK212048
Jan 15, 2026Intuitive Surgical, Inc.
da Vinci SP, SP Access Port Kit, Large Incision Reference Numbers:430073 (2.7-4cm,SP1098, Box) & 430075 (2.7-7cm,SP1098,Box)
Open, Classified		 NAYK202571
Dec 19, 2025Intuitive Surgical, Inc.
da Vinci 5, Surgeon Console Column Motor Connector; ASSY,DV5 CONSOLE,SSC,IS5000; Part Number: 380730-40
Open, Classified		 NAYK232610
Mar 12, 2025Intuitive Surgical, Inc.
Brand Name: Da Vinci 5 Product Name: ASSY,DV5 CONSOLE,IS5000 Foot Tray Pedals Model/Catalog Number: 380730 Software Version: N/A . Refer to HHE for additional details. Component: N/A
Open, Classified		 NAYK232610
Jan 16, 2025Intuitive Surgical, Inc.
8MM, Small Graptor REF 470318 Is a grasping retractor Instrument used with the da Vinci X/Xi Surgical Systems in a wide variety of procedures to perform a variety of surgical tasks including manipula
Open, Classified		 NAYK131861
Jan 16, 2025Intuitive Surgical, Inc.
8MM, Tenaculum Forceps REF 470207 Instrument used with the da Vinci X/Xi Surgical Systems in a wide variety of procedures to perform a variety of surgical tasks including manipulation and retraction
Open, Classified		 NAYK131861
Jan 10, 2025Intuitive Surgical, Inc.
8MM,FORCE BIPOLAR,IS4000 REF 471405
Open, Classified		 NAYK180351
K214095
Jan 10, 2025Intuitive Surgical, Inc.
8MM,LONG BIPOLAR GRASPER,IS4000 REF 471400
Open, Classified		 NAYK150837
K214095
Jan 10, 2025Intuitive Surgical, Inc.
8MM,CURVED BIPOLAR DISSECTOR,IS4000 REF 471344
Open, Classified		 NAYK131861
K214095
Jan 10, 2025Intuitive Surgical, Inc.
8MM,MEGA SUTURECUT ND,IS4000 REF 471309
Open, Classified		 NAYK131861
K214095
Jan 10, 2025Intuitive Surgical, Inc.
8MM,LARGE SUTURECUT NEEDLE DRIVER,IS4000 REF 471296
Open, Classified		 NAYK150284
K214095
Jan 10, 2025Intuitive Surgical, Inc.
8MM,FENESTRATED BIPOLAR FORCEPS,IS4000 REF 471205
Open, Classified		 NAYK131861
K214095
Jan 10, 2025Intuitive Surgical, Inc.
8MM,COBRA GRASPER,IS4000 REF 471190
Open, Classified		 NAYK150284
K214095
Jan 10, 2025Intuitive Surgical, Inc.
8MM,MARYLAND BIPOLAR FORCEPS,IS4000 REF 471172
Open, Classified		 NAYK131861
K214095
Jan 10, 2025Intuitive Surgical, Inc.
8MM,MICRO BIPOLAR FORCEPS,IS4000 REF 471171
Open, Classified		 NAYK131861
K214095
Jan 10, 2025Intuitive Surgical, Inc.
8MM,PROGRASP FORCEPS,IS4000 REF 471093
Open, Classified		 NAYK131861
K214095
Jan 10, 2025Intuitive Surgical, Inc.
8MM,CADIERE FORCEPS,IS4000 REF 471049
Open, Classified		 NAYK150284
K214095
Jan 10, 2025Intuitive Surgical, Inc.
8MM,LONG TIP FORCEPS,IS4000 REF 471048
Open, Classified		 NAYK131861
K214095
Jan 10, 2025Intuitive Surgical, Inc.
8MM,FORCE BIPOLAR,IS4000 REF 470405
Open, Classified		 NAYK180351
Jan 10, 2025Intuitive Surgical, Inc.
8MM,HORIZON SMALL CLIP APPLIER,IS4000 REF 470401
Open, Classified		 NAYK150837
Jan 10, 2025Intuitive Surgical, Inc.
8MM,TIP-UP FENESTRATED GRASPER,IS4000 REF 470347
Open, Classified		 NAYK131861
Jan 10, 2025Intuitive Surgical, Inc.
8MM,CURVED BIPOLAR DISSECTOR,IS4000 REF 470344
Open, Classified		 NAYK131861
Jan 10, 2025Intuitive Surgical, Inc.
8MM,MEDIUM-LARGE CLIP APPLIER,IS4000 REF 470327
Open, Classified		 NAYK131861
Jan 10, 2025Intuitive Surgical, Inc.
8MM,SMALL GRASPING RETRACTOR,IS4000 REF 470318
Open, Classified		 NAYK131861
Jan 10, 2025Intuitive Surgical, Inc.
8MM,MEGA SUTURECUT ND,IS4000 REF 470309
Open, Classified		 NAYK131861
Jan 10, 2025Intuitive Surgical, Inc.
8MM,LARGE SUTURECUT NEEDLE DRIVER,IS4000 REF 470296
Open, Classified		 NAYK150284
Jan 10, 2025Intuitive Surgical, Inc.
8MM,DUAL BLADE RETRACTOR,IS4000 REF 470249
Open, Classified		 NAYK131861
Jan 10, 2025Intuitive Surgical, Inc.
8MM,ATRIAL RETRACTOR SHORT RIGHT,IS4000 REF 470246
Open, Classified		 NAYK131861
Jan 10, 2025Intuitive Surgical, Inc.
8MM,LARGE HEM-O-LOK CLIP APPLIER,IS4000 REF 470230
Open, Classified		 NAYK131861
Jan 10, 2025Intuitive Surgical, Inc.
8MM,TENACULUM FORCEPS,IS4000 REF 470207
Open, Classified		 NAYK131861
Jan 10, 2025Intuitive Surgical, Inc.
8MM,FENESTRATED BIPOLAR FORCEPS,IS4000 REF 470205
Open, Classified		 NAYK131861
Jan 10, 2025Intuitive Surgical, Inc.
8MM,MEGA NEEDLE DRIVER,IS4000 REF 470194
Open, Classified		 NAYK150284
Jan 10, 2025Intuitive Surgical, Inc.
8MM,RESANO FORCEPS,IS4000 REF 470181
Open, Classified		 NAYK131861
Jan 10, 2025Intuitive Surgical, Inc.
8MM,MARYLAND BIPOLAR FORCEPS,IS4000 REF 470172
Open, Classified		 NAYK131861
Jan 10, 2025Intuitive Surgical, Inc.
8MM,MICRO BIPOLAR FORCEPS,IS4000 REF 470171
Open, Classified		 NAYK131861
Jan 10, 2025Intuitive Surgical, Inc.
8MM,PROGRASP FORCEPS,IS4000 REF 470093
Open, Classified		 NAYK131861

Newest 50 of 277.

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