510(k) Report

510(k) · Decided

Recalled · Class II · 2025

da Vinci SP Surgical System, Model SP1098, EndoWrist SP Instruments, and Accessories

K202571510(k) TraditionalDecided Nov 12, 202069-day reviewClass II21 CFR 876.1500Recalls 1

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Intuitive Surgical, Inc. · NAY System, Surgical, Computer Controlled Instrument

Cleared on Nov 12, 2020 as substantially equivalent to K182371 (Intuitive Surgical, Inc., 2019) after a 69-day review. Its family tree reaches back 17 generations to 1994. 14 later devices descend from it. It has been recalled once.

Decided
Nov 12, 2020
Review
69 days
Class
Class II
Product code
NAY
Recalls
1
Predicates
1

Its longest line of descent runs back 17 generations to K930667 (1994). 93 ancestors in all, the oldest K811390 (1981). 14 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2009: 5 other ancestors2006: 3 other ancestors2005: 2 other ancestors2004: 4 other ancestors2002: 3 other ancestors2001: 8 other ancestors2012: 1 other ancestor2011: 1 other ancestor2003: 2 other ancestors1999: 3 other ancestors1997: 7 other ancestors1993: 3 other ancestors2010: 1 other ancestor2008: 2 other ancestors1998: 3 other ancestors1995: 6 other ancestors1994: 6 other ancestors1992: 4 other ancestors1991: 5 other ancestors2007: 2 other ancestors1990: 1 other ancestor1988: 2 other ancestors1981: 1 other ancestor1996: 1 other ancestor2025: 7 descendants cleared2023: 2 descendants cleared2024: 4 descendants cleared2026: 1 descendant clearedReference device: K090275 · Gelport Single Incision Access System · Applied Medical Resources Corp. · 2009K930667 · Reusable Laparoscopic Instruments · Snowden-Pencer · 1994 · recalledK960400 · Diamond-Touch and Micro Diamond-Touch Instruments/Diamond-Line Instruments/Diamond-Port (Access Parts) · Snowden-Pencer · 1996K990144 · Intuitive Surgical Endoscopic Instruments, Intuitive Surgical Endoscopic Instrument Control System · Intuitive Surgical, Inc. · 2000 · recalledK021036 · Intuitive Surgical DA Vinci Surgical System, Model IS1000 · Intuitive Surgical, Inc. · 2002 · recalled×5: 5 generations cleared close together, K040237 (2004), K043153 (2004), K050005 (2005), K050404 (2005), K050802 (2005) K063220 · DA Vinci S Surgical System-V1.1, Model IS2000 · Intuitive Surgical, Inc. · 2006 · recalledK081137 · Intuitive Surgical DA Vinci SI Surgical System: Model IS3000 · Intuitive Surgical, Inc. · 2009 · recalled×2: 2 generations cleared close together, K112208 (2011), K120215 (2012) K122532 · DA Vinci Single-Site Instruments and Accessories · Intuitive Surgical, Inc. · 2013 · recalledK131962 · DA Vinci SP Surgical System, Endowrist SP Instruments, and Accessories · Intuitive Surgical, Inc. · 2014K173906 · da Vinci SP Surgical System, EndoWrist SP Instruments, and Accessories · Intuitive Surgical, Inc. · 2018 · recalledK182371 · da Vinci SP Surgical System, EndoWrist SP Instruments, and Accessories · Intuitive Surgical, Inc. · 2019 · recalled19801990200020102020
Other ancestors, by generationDescendants, by generation 2 generations back: 1 other ancestor3 generations back: 12 other ancestors4 generations back: 11 other ancestors5 generations back: 18 other ancestors6 generations back: 17 other ancestors7 generations back: 12 other ancestors8 generations back: 5 other ancestors 1 generation forward: 2 descendants2 generations forward: 1 descendant3 generations forward: 2 descendants4 generations forward: 2 descendants5 generations forward: 2 descendants6 generations forward: 4 descendants7 generations forward: 1 descendant K182371 · da Vinci SP Surgical System, EndoWrist SP Instruments, and Accessories · Intuitive Surgical, Inc. · 2019 · recalledK173906 · da Vinci SP Surgical System, EndoWrist SP Instruments, and Accessories · Intuitive Surgical, Inc. · 2018 · recalledK131962 · DA Vinci SP Surgical System, Endowrist SP Instruments, and Accessories · Intuitive Surgical, Inc. · 2014K122532 · DA Vinci Single-Site Instruments and Accessories · Intuitive Surgical, Inc. · 2013 · recalledK120215 · Single-Site Medium-Large Clip Applier, Single-Site Cadiere Grasper, Single-Site Fundus Grasper, Single-Site Crocodile · Intuitive Surgical, Inc. · 2012 · recalledK112208 · Intutive Surgical DA Vinci Single Site Instruments and Accessories · Intuitive Surgical, Inc. · 2011 · recalledK081137 · Intuitive Surgical DA Vinci SI Surgical System: Model IS3000 · Intuitive Surgical, Inc. · 2009 · recalledK063220 · DA Vinci S Surgical System-V1.1, Model IS2000 · Intuitive Surgical, Inc. · 2006 · recalledK050802 · Modification to Intuitive Surgical DA Vinci Surgical System and Endoscopic Instruments · Intuitive Surgical, Inc. · 2005K050404 · Intuitive Surgical DA Vinci Surgical System and Endoscopic Instruments · Intuitive Surgical, Inc. · 2005K050005 · Intuitive Surgical Monopolar Curved Scissors, Model 400179; Tip Cover Accessory, Model 400180 · Intuitive Surgical, Inc. · 2005 · recalledK043153 · Intuitive Surgical DA Vinci Surgical System and Endoscopic Instruments, Models IS1200 & IS1000 · Intuitive Surgical, Inc. · 2004K040237 · Intuitive Surgical DA Vinci Endoscopic Instrument Control System and Endoscopic Instruments · Intuitive Surgical, Inc. · 2004K021036 · Intuitive Surgical DA Vinci Surgical System, Model IS1000 · Intuitive Surgical, Inc. · 2002 · recalledK990144 · Intuitive Surgical Endoscopic Instruments, Intuitive Surgical Endoscopic Instrument Control System · Intuitive Surgical, Inc. · 2000 · recalledK960400 · Diamond-Touch and Micro Diamond-Touch Instruments/Diamond-Line Instruments/Diamond-Port (Access Parts) · Snowden-Pencer · 1996K930667 · Reusable Laparoscopic Instruments · Snowden-Pencer · 1994 · recalled−15−10−50+5
  1. Root · 17 generations backK930667 Reusable Laparoscopic InstrumentsSnowden-Pencer · 1994 · Recalled
  2. 13 generations between
  3. 3 generations backK131962 DA Vinci SP Surgical System, Endowrist SP Instruments, and AccessoriesIntuitive Surgical, Inc. · 2014
  4. 2 generations backK173906 da Vinci SP Surgical System, EndoWrist SP Instruments, and AccessoriesIntuitive Surgical, Inc. · 2018 · Recalled
  5. 1 generation backK182371 da Vinci SP Surgical System, EndoWrist SP Instruments, and AccessoriesIntuitive Surgical, Inc. · 2019 · Recalled
  6. This deviceK202571 da Vinci SP Surgical System, Model SP1098, EndoWrist SP Instruments…Intuitive Surgical, Inc. · 2020
  7. Descendant · cites it directly · 12 of its ownK230033 Da Vinci SP Surgical System (SP1098)Intuitive Surgical, Inc. · 2023
  8. Descendant · 2 generations on · 11 of its ownK231798 da Vinci SP Surgical SystemIntuitive Surgical, Inc. · 2023
  9. Descendant · 3 generations on · 9 of its ownK240502 da Vinci SP Surgical System (SP1098)Intuitive Surgical, Inc. · 2024
  10. Descendant · 4 generations on · 7 of its ownK242318 da Vinci SP Surgical System (SP1098)Intuitive Surgical, Inc. · 2024
  11. Descendant · 5 generations on · 5 of its ownK243714 da Vinci SP Surgical System (SP1098)Intuitive Surgical, Inc. · 2025
Show all 17 generations
  1. Root · 17 generations backK930667 Reusable Laparoscopic InstrumentsSnowden-Pencer · 1994 · Recalled
  2. 16 generations backK960400 Diamond-Touch and Micro Diamond-Touch Instruments/Diamond-Line…Snowden-Pencer · 1996
  3. 15 generations backK990144 Intuitive Surgical Endoscopic Instruments, Intuitive Surgical…Intuitive Surgical, Inc. · 2000 · Recalled
  4. 14 generations backK021036 Intuitive Surgical DA Vinci Surgical System, Model IS1000Intuitive Surgical, Inc. · 2002 · Recalled
  5. 13 generations backK040237 Intuitive Surgical DA Vinci Endoscopic Instrument Control System and…Intuitive Surgical, Inc. · 2004
  6. 12 generations backK043153 Intuitive Surgical DA Vinci Surgical System and Endoscopic…Intuitive Surgical, Inc. · 2004
  7. 11 generations backK050005 Intuitive Surgical Monopolar Curved Scissors, Model 400179; Tip…Intuitive Surgical, Inc. · 2005 · Recalled
  8. 10 generations backK050404 Intuitive Surgical DA Vinci Surgical System and Endoscopic InstrumentsIntuitive Surgical, Inc. · 2005
  9. 9 generations backK050802 Modification to Intuitive Surgical DA Vinci Surgical System and…Intuitive Surgical, Inc. · 2005
  10. 8 generations backK063220 DA Vinci S Surgical System-V1.1, Model IS2000Intuitive Surgical, Inc. · 2006 · Recalled
  11. 7 generations backK081137 Intuitive Surgical DA Vinci SI Surgical System: Model IS3000Intuitive Surgical, Inc. · 2009 · Recalled
  12. 6 generations backK112208 Intutive Surgical DA Vinci Single Site Instruments and AccessoriesIntuitive Surgical, Inc. · 2011 · Recalled
  13. 5 generations backK120215 Single-Site Medium-Large Clip Applier, Single-Site Cadiere Grasper…Intuitive Surgical, Inc. · 2012 · Recalled
  14. 4 generations backK122532 DA Vinci Single-Site Instruments and AccessoriesIntuitive Surgical, Inc. · 2013 · Recalled
  15. 3 generations backK131962 DA Vinci SP Surgical System, Endowrist SP Instruments, and AccessoriesIntuitive Surgical, Inc. · 2014
  16. 2 generations backK173906 da Vinci SP Surgical System, EndoWrist SP Instruments, and AccessoriesIntuitive Surgical, Inc. · 2018 · Recalled
  17. 1 generation backK182371 da Vinci SP Surgical System, EndoWrist SP Instruments, and AccessoriesIntuitive Surgical, Inc. · 2019 · Recalled
  18. This deviceK202571 da Vinci SP Surgical System, Model SP1098, EndoWrist SP Instruments…Intuitive Surgical, Inc. · 2020

Showing 5 of 14 descendants. See all descendants

Descendants cleared per year

2023: 22024: 42025: 72026: 1
2023high 7 (2025) · low 1 (2026)2026

Most influential descendants

Showing 5 of 14 · See all
  • K230033Da Vinci SP Surgical System (SP1098)Intuitive Surgical, Inc. · 2023 · cites it directly12descendants
  • K231798da Vinci SP Surgical SystemIntuitive Surgical, Inc. · 2023 · 2 generations on11descendants
  • K240502da Vinci SP Surgical System (SP1098)Intuitive Surgical, Inc. · 2024 · 3 generations on9descendants
  • K242318da Vinci SP Surgical System (SP1098)Intuitive Surgical, Inc. · 2024 · 4 generations on7descendants
  • K243714da Vinci SP Surgical System (SP1098)Intuitive Surgical, Inc. · 2025 · 5 generations on5descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−17K930667Reusable Laparoscopic InstrumentsSnowden-Pencer199415
−16K960400Diamond-Touch and Micro Diamond-Touch Instruments/Diamond-Line…Snowden-Pencer1996—
−15K990144Intuitive Surgical Endoscopic Instruments, Intuitive Surgical Endoscopic…Intuitive Surgical, Inc.20003
−14K021036Intuitive Surgical DA Vinci Surgical System, Model IS1000Intuitive Surgical, Inc.200218
−13K040237Intuitive Surgical DA Vinci Endoscopic Instrument Control System and…Intuitive Surgical, Inc.2004—
−12K043153Intuitive Surgical DA Vinci Surgical System and Endoscopic Instruments, Models…Intuitive Surgical, Inc.2004—
−11K050005Intuitive Surgical Monopolar Curved Scissors, Model 400179; Tip Cover…Intuitive Surgical, Inc.20052
−10K050404Intuitive Surgical DA Vinci Surgical System and Endoscopic InstrumentsIntuitive Surgical, Inc.2005—
−9K050802Modification to Intuitive Surgical DA Vinci Surgical System and Endoscopic…Intuitive Surgical, Inc.2005—
−8K063220DA Vinci S Surgical System-V1.1, Model IS2000Intuitive Surgical, Inc.20064
−7K081137Intuitive Surgical DA Vinci SI Surgical System: Model IS3000Intuitive Surgical, Inc.200925
−6K112208Intutive Surgical DA Vinci Single Site Instruments and AccessoriesIntuitive Surgical, Inc.201112
−5K120215Single-Site Medium-Large Clip Applier, Single-Site Cadiere Grasper…Intuitive Surgical, Inc.20123
−4K122532DA Vinci Single-Site Instruments and AccessoriesIntuitive Surgical, Inc.20136
−3K131962DA Vinci SP Surgical System, Endowrist SP Instruments, and AccessoriesIntuitive Surgical, Inc.2014—
−2K173906da Vinci SP Surgical System, EndoWrist SP Instruments, and AccessoriesIntuitive Surgical, Inc.20189
−1K182371da Vinci SP Surgical System, EndoWrist SP Instruments, and AccessoriesIntuitive Surgical, Inc.20194
0 (this device)K202571da Vinci SP Surgical System, Model SP1098, EndoWrist SP Instruments, and…Intuitive Surgical, Inc.2020—
+1K230033Da Vinci SP Surgical System (SP1098)Intuitive Surgical, Inc.2023—
+2K231798da Vinci SP Surgical SystemIntuitive Surgical, Inc.2023—
+3K240502da Vinci SP Surgical System (SP1098)Intuitive Surgical, Inc.2024—
+4K242318da Vinci SP Surgical System (SP1098)Intuitive Surgical, Inc.2024—
+5K243714da Vinci SP Surgical System (SP1098)Intuitive Surgical, Inc.2025—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198110
198820
199010
199150
199240
199330
199460
199560
199610
199770
199830
199930
200180
200230
200320
200440
200520
200630
200720
200820
200950
201010
201110
201210

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202320
202440
202570
202610
FIG. 1 — Lineage of K202571, 1994–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in NAY? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new NAY device

  1. #1 K232610 da Vinci Surgical System Model IS5000, da…score 32.9 · 24 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K182371da Vinci SP Surgical System, EndoWrist SP Instruments, and Accessories
Summary page 5
…Controlled Instrument) Predicate Device: da Vinci SP® Surgical System, Model SP1098, EndoWrist SP™ Instruments, and Accessories (K182371) Reference Device: GelPOINT single incision access system (Applied Medical, K090275) D…
Intuitive Surgical, Inc.20194
†K090275Gelport Single Incision Access SystemApplied Medical Resources Corp.2009—

Also cleared against K182371: 1 other device →

What descends from it? (14)

See all 14

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K230033Da Vinci SP Surgical System (SP1098)Intuitive Surgical, Inc.202312
K243582da Vinci SP Advanced Access Port Kit (432701)Intuitive Surgical, Inc.20250

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Dec 15, 2025Class IIZ-1096-2026Packaging change controlAccess Port System tray may develop cracks potentially resulting in a sterility breach.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 26 years and passes through 2 companies; a new generation was cleared every 1.4 years on median.
  • 24 of the 93 ancestors have a recall of any class.
  • Of its descendants, K230033 (Intuitive Surgical, Inc., 2023) has gone furthest, with 12 descendants of its own.
  • 1 other device also cites its predicate K182371.

How does its category compare?

All NAY devices

NAY System, Surgical, Computer Controlled Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.

FDA decisions per year · NAY

16in 2025

2008: 42009: 32010: 12011: 72012: 42013: 42014: 92015: 32016: 82017: 162018: 152019: 82020: 92021: 112022: 62023: 52024: 102025: 162026 (partial year): 7
2007high 16 (2017) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · NAY

117in 2025

2008: 189 days median2009: 253 days median2011: 191 days median2012: 106 days median2013: 144 days median2014: 143 days median2015: 99 days median2016: 197 days median2017: 107 days median2018: 152 days median2019: 73 days median2020: 212 days median2021: 61 days median2022: 57 days median2023: 141 days median2024: 126 days median2025: 117 days median2026 (partial year): 89 days median
2007high 253 (2009) · low 57 (2022)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · NAY

1in 2025

2007: 112008: 32009: 12011: 22012: 12013: 62014: 252015: 32016: 12017: 12018: 22019: 52021: 32022: 32023: 2, 1 Class I2024: 402025: 12026 (partial year): 4, 1 Class I
2007high 40 (2024) · low 0 (2010)2026

Class I (2 since 2007) Class II/III not classified

Adverse event reports per year · NAY

48,456in 2025

2007: 1332008: 2242009: 3802010: 6232011: 5012012: 1,5522013: 6,2172014: 6,1352015: 1,7222016: 1,0772017: 1,0492018: 1,0742019: 1,1542020: 1,5582021: 1,9972022: 5,7272023: 10,8982024: 12,8722025: 48,456
2007high 48,456 (2025) · low 133 (2007)2025

MAUDE reports naming product code NAY, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—11133
200841893224
200932531380
20101—0623
201171912501
2012410611,552
2013414466,217
20149143256,135
201539931,722
2016819711,077
20171610711,049
20181515221,074
201987351,154
2020921201,558
2021116131,997
202265735,727
202351412 (1)10,898
2024101264012,872
202516117148,456
20267894 (1)—

What is it indicated for?

da Vinci SP ® Surgical System, Model SP1098: The Intuitive Surgical ® Endoscopic Instrument Control System (da Vinci SP ® Surgical System, Model SP1098) is intended to assist in the accurate control of Intuitive Surgical® EndoWrist SP™ Instruments during urologic surgical procedures that are appropriate for a single port approach and transoral otolaryngology surgical procedures in the oropharynx restricted to benign tumors and malignant tumors classified…

Read the full statement (238 words)

da Vinci SP ® Surgical System, Model SP1098:

The Intuitive Surgical ® Endoscopic Instrument Control System (da Vinci SP ® Surgical System, Model SP1098) is intended to assist in the accurate control of Intuitive Surgical® EndoWrist SP™ Instruments during urologic surgical procedures that are appropriate for a single port approach and transoral otolaryngology surgical procedures in the oropharynx restricted to benign tumors and malignant tumors classified as T1 and T2. The system is indicated for adult use. It is intended for use by trained physicians in an operating room environment in accordance with the representative, specific procedures set forth in the Professional Instructions for Use.

EndoWrist SP ™ Instruments:

Intuitive Surgical ® EndoWrist SP ™ Instruments are controlled by the da Vinci SP ® Surgical System, Model SP1098, and include flexible endoscopes, blunt and sharp endoscopic dissectors, scissors, forceps/pick-ups, needle holders, endoscopic retractors, electrocautery and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, and suturing through a single port. The system is indicated for urologic surgical procedures that are appropriate for a single port approach and transoral otolaryngology surgical procedures in the oropharynx restricted to benign tumors and malignant tumors classified as T1 and T2. The system is indicated for adult use. It is intended for use by trained physicians in an operating room environment in accordance with the representative, specific procedures set forth in the Professional Instructions for Use.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K182371

1 other device cites the same predicate.

  • K192717da Vinci SP Surgical SystemIntuitive Surgical, Inc. · 20201 recall

More from Intuitive Surgical, Inc.

181 FDA decisions under this applicant name. See the company

  • K262455da Vinci 5 Handheld Camera Head (470080);da Vinci 5 Handheld Camera Laparoscope, 0 degree (470081);da Vinci…Intuitive Surgical, Inc. · 2026
  • K261823da Vinci Surgical System, Model IS5000Intuitive Surgical, Inc. · 2026
  • K253702Intuitive Endoluminal Gastrointestinal System (IG1000)Intuitive Surgical, Inc. · 2026
  • K261824da Vinci Surgical System, Model IS5000Intuitive Surgical, Inc. · 2026
  • K261249Universal Seal (5-12 mm)Intuitive Surgical, Inc. · 2026

Recent decisions in NAY

The NAY category page

  • K261823da Vinci Surgical System, Model IS5000Intuitive Surgical, Inc. · 2026
  • K261824da Vinci Surgical System, Model IS5000Intuitive Surgical, Inc. · 2026
  • K260695da Vinci Firefly Imaging SystemIntuitive Surgical · 2026
  • K254192Senhance Ultrasonic SystemAsensus Surgical · 2026
  • K253986da Vinci Force Feedback InstrumentsIntuitive Surgical, Inc. · 2026

https://510kreport.com/device/K202571 · printed Nov 5, 2026

Cite this page

510(k) Report. “K202571: da Vinci SP Surgical System, Model SP1098, EndoWrist SP Instruments, and Accessories.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K202571

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026