ClearanceBrief
Panels › Gastroenterology, Urology › Product code NAY · Class 2

System, Surgical, Computer Controlled Instrument

Regulation 876.1500

9510(k)s in 12 months (166 all time)
16recalls in 12 months (248 all time)
244recalls that name a 510(k)
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Top companies in NAY

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 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
Jan 10, 2025Intuitive Surgical, Inc.
8MM,CADIERE FORCEPS,IS4000 REF 470049
Open, Classified
NAYK150284

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