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)
Top companies in NAY
| Company | 510(k)s | Recalls |
|---|---|---|
| Intuitive Surgical | 147 | 246 |
| Transenterix, Inc. | 9 | 0 |
| Asensus Surgical | 6 | 1 |
| Aktormed GmbH | 2 | 0 |
| Computer Motion, Inc. | 2 | 0 |
| Olympus Corporation of the Americas | 0 | 1 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 10, 2026 | Intuitive Surgical, Inc. da Vinci SP Instrument Arm Drape, SP, 1-PACK, Part Number: 430013-13, 430013-15 Open, Classified |
NAY | K173906 K182371 |
| Jun 22, 2026 | Intuitive Surgical, Inc. Da Vinci ASSY, PSS, SP1098, Part Number: 380601 Open, Classified |
NAY | K173906 K182371 |
| Jun 4, 2026 | Intuitive 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 |
NAY | K232610 |
| May 1, 2026 | Intuitive 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 |
NAY | K131861 K171294 |
| May 1, 2026 | Intuitive Surgical, Inc. Intuitive 8 mm SureForm 30 Gray Reloads
Reference Numbers: 48230M-05 and 48230M-06 Open, Classified |
NAY | K211997 K222839 +1 |
| Mar 30, 2026 | Intuitive 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 |
NAY | K050369 |
| Mar 30, 2026 | Intuitive 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 |
NAY | K050369 |
| Mar 30, 2026 | Intuitive 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 |
NAY | K050369 |
| Mar 30, 2026 | Intuitive 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 |
NAY | K050369 |
| Mar 30, 2026 | Intuitive 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 |
NAY | K050369 |
| Mar 30, 2026 | Intuitive 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 |
NAY | K050369 K180033 |
| Feb 18, 2026 | Intuitive Surgical, Inc. Da Vinci 5
ASSY, DV5 CONSOLE, IS5000
Model/Catalog Number: 380730
Used for minimally invasive surgery. Open, Classified |
NAY | K232610 |
| Feb 12, 2026 | Intuitive Surgical, Inc. da Vinci 5 Surgeon Console Viewer Display, ASSY, DV5 CONSOLE, IS5000, Part Number: 380730-45 Open, Classified |
NAY | K232610 |
| Feb 2, 2026 | Intuitive 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 |
NAY | K131861 K171294 +1 |
| Jan 15, 2026 | Intuitive 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 |
NAY | K202571 |
| Dec 19, 2025 | Intuitive Surgical, Inc. da Vinci 5, Surgeon Console Column Motor Connector; ASSY,DV5 CONSOLE,SSC,IS5000; Part Number: 380730-40 Open, Classified |
NAY | K232610 |
| Mar 12, 2025 | Intuitive 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 |
NAY | K232610 |
| Jan 16, 2025 | Intuitive 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 |
NAY | K131861 |
| Jan 16, 2025 | Intuitive 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 |
NAY | K131861 |
| Jan 10, 2025 | Intuitive Surgical, Inc. 8MM,FORCE BIPOLAR,IS4000 REF 471405 Open, Classified |
NAY | K180351 K214095 |
| Jan 10, 2025 | Intuitive Surgical, Inc. 8MM,LONG BIPOLAR GRASPER,IS4000 REF 471400 Open, Classified |
NAY | K150837 K214095 |
| Jan 10, 2025 | Intuitive Surgical, Inc. 8MM,CURVED BIPOLAR DISSECTOR,IS4000 REF 471344 Open, Classified |
NAY | K131861 K214095 |
| Jan 10, 2025 | Intuitive Surgical, Inc. 8MM,MEGA SUTURECUT ND,IS4000 REF 471309 Open, Classified |
NAY | K131861 K214095 |
| Jan 10, 2025 | Intuitive Surgical, Inc. 8MM,LARGE SUTURECUT NEEDLE DRIVER,IS4000 REF 471296 Open, Classified |
NAY | K150284 K214095 |
| Jan 10, 2025 | Intuitive Surgical, Inc. 8MM,FENESTRATED BIPOLAR FORCEPS,IS4000 REF 471205 Open, Classified |
NAY | K131861 K214095 |
| Jan 10, 2025 | Intuitive Surgical, Inc. 8MM,COBRA GRASPER,IS4000 REF 471190 Open, Classified |
NAY | K150284 K214095 |
| Jan 10, 2025 | Intuitive Surgical, Inc. 8MM,MARYLAND BIPOLAR FORCEPS,IS4000 REF 471172 Open, Classified |
NAY | K131861 K214095 |
| Jan 10, 2025 | Intuitive Surgical, Inc. 8MM,MICRO BIPOLAR FORCEPS,IS4000 REF 471171 Open, Classified |
NAY | K131861 K214095 |
| Jan 10, 2025 | Intuitive Surgical, Inc. 8MM,PROGRASP FORCEPS,IS4000 REF 471093 Open, Classified |
NAY | K131861 K214095 |
| Jan 10, 2025 | Intuitive Surgical, Inc. 8MM,CADIERE FORCEPS,IS4000 REF 471049 Open, Classified |
NAY | K150284 K214095 |
| Jan 10, 2025 | Intuitive Surgical, Inc. 8MM,LONG TIP FORCEPS,IS4000 REF 471048 Open, Classified |
NAY | K131861 K214095 |
| Jan 10, 2025 | Intuitive Surgical, Inc. 8MM,FORCE BIPOLAR,IS4000 REF 470405 Open, Classified |
NAY | K180351 |
| Jan 10, 2025 | Intuitive Surgical, Inc. 8MM,HORIZON SMALL CLIP APPLIER,IS4000 REF 470401 Open, Classified |
NAY | K150837 |
| Jan 10, 2025 | Intuitive Surgical, Inc. 8MM,TIP-UP FENESTRATED GRASPER,IS4000 REF 470347 Open, Classified |
NAY | K131861 |
| Jan 10, 2025 | Intuitive Surgical, Inc. 8MM,CURVED BIPOLAR DISSECTOR,IS4000 REF 470344 Open, Classified |
NAY | K131861 |
| Jan 10, 2025 | Intuitive Surgical, Inc. 8MM,MEDIUM-LARGE CLIP APPLIER,IS4000 REF 470327 Open, Classified |
NAY | K131861 |
| Jan 10, 2025 | Intuitive Surgical, Inc. 8MM,SMALL GRASPING RETRACTOR,IS4000 REF 470318 Open, Classified |
NAY | K131861 |
| Jan 10, 2025 | Intuitive Surgical, Inc. 8MM,MEGA SUTURECUT ND,IS4000 REF 470309 Open, Classified |
NAY | K131861 |
| Jan 10, 2025 | Intuitive Surgical, Inc. 8MM,LARGE SUTURECUT NEEDLE DRIVER,IS4000 REF 470296 Open, Classified |
NAY | K150284 |
| Jan 10, 2025 | Intuitive Surgical, Inc. 8MM,DUAL BLADE RETRACTOR,IS4000 REF 470249 Open, Classified |
NAY | K131861 |
| Jan 10, 2025 | Intuitive Surgical, Inc. 8MM,ATRIAL RETRACTOR SHORT RIGHT,IS4000 REF 470246 Open, Classified |
NAY | K131861 |
| Jan 10, 2025 | Intuitive Surgical, Inc. 8MM,LARGE HEM-O-LOK CLIP APPLIER,IS4000 REF 470230 Open, Classified |
NAY | K131861 |
| Jan 10, 2025 | Intuitive Surgical, Inc. 8MM,TENACULUM FORCEPS,IS4000 REF 470207 Open, Classified |
NAY | K131861 |
| Jan 10, 2025 | Intuitive Surgical, Inc. 8MM,FENESTRATED BIPOLAR FORCEPS,IS4000 REF 470205 Open, Classified |
NAY | K131861 |
| Jan 10, 2025 | Intuitive Surgical, Inc. 8MM,MEGA NEEDLE DRIVER,IS4000 REF 470194 Open, Classified |
NAY | K150284 |
| Jan 10, 2025 | Intuitive Surgical, Inc. 8MM,RESANO FORCEPS,IS4000 REF 470181 Open, Classified |
NAY | K131861 |
| Jan 10, 2025 | Intuitive Surgical, Inc. 8MM,MARYLAND BIPOLAR FORCEPS,IS4000 REF 470172 Open, Classified |
NAY | K131861 |
| Jan 10, 2025 | Intuitive Surgical, Inc. 8MM,MICRO BIPOLAR FORCEPS,IS4000 REF 470171 Open, Classified |
NAY | K131861 |
| Jan 10, 2025 | Intuitive Surgical, Inc. 8MM,PROGRASP FORCEPS,IS4000 REF 470093 Open, Classified |
NAY | K131861 |
| Jan 10, 2025 | Intuitive Surgical, Inc. 8MM,CADIERE FORCEPS,IS4000 REF 470049 Open, Classified |
NAY | K150284 |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.