510(k) · Cleared
Clearedda Vinci S/Si (IS2000/IS3000) 5mm and 8mm Reusable Instruments, da Vinci Xi/X (IS4000/IS4200) 8mm Reusable Instruments
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Intuitive Surgical, Inc. · NAY System, Surgical, Computer Controlled Instrument
Cleared on Feb 10, 2021 as substantially equivalent to K170644 (Intuitive Surgical, Inc., 2017) and 1 other predicate after a 61-day review. Its family tree reaches back 1 generation to 2017. 6 later devices descend from it.
- Decided
- Feb 10, 2021
- Review
- 61 days
- Class
- Class II
- Product code
- NAY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K170644 (2017). 2 ancestors in all. 6 later devices descend from it, 6 citing it directly.
- Root · 1 generation backK170644 da Vinci S/Si EndoWrist Instruments and Accessories, Harmonic ACE…Intuitive Surgical, Inc. · 2017
- This deviceK203632 da Vinci S/Si (IS2000/IS3000) 5mm and 8mm Reusable Instruments, da…Intuitive Surgical, Inc. · 2021
- Descendant · cites it directly · 0 of its ownK250417 Remanufactured EndoWrist Cobra Grasper (420190)Rebotix · 2025
- Descendant · cites it directly · 0 of its ownK250539 Remanufactured EndoWrist Tenaculum Forceps (420207)Rebotix · 2025
- Descendant · cites it directly · 0 of its ownK250387 Remanufactured EndoWrist Long Tip Forceps (420048)Rebotix · 2025
- Descendant · cites it directly · 0 of its ownK250399 Remanufactured EndoWrist Cadiere Forceps (420049)Rebotix · 2025
- Descendant · cites it directly · 0 of its ownK241872 Remanufactured EndoWrist ProGrasp Forceps (420093)Rebotix · 2024
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K250417Remanufactured EndoWrist Cobra Grasper (420190)Rebotix · 2025 · cites it directly0descendants
- K250539Remanufactured EndoWrist Tenaculum Forceps (420207)Rebotix · 2025 · cites it directly0descendants
- K250387Remanufactured EndoWrist Long Tip Forceps (420048)Rebotix · 2025 · cites it directly0descendants
- K250399Remanufactured EndoWrist Cadiere Forceps (420049)Rebotix · 2025 · cites it directly0descendants
- K241872Remanufactured EndoWrist ProGrasp Forceps (420093)Rebotix · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K170644 | da Vinci S/Si EndoWrist Instruments and Accessories, Harmonic ACE Curved… | Intuitive Surgical, Inc. | 2017 | — |
| 0 (this device) | K203632 | da Vinci S/Si (IS2000/IS3000) 5mm and 8mm Reusable Instruments, da Vinci Xi/X… | Intuitive Surgical, Inc. | 2021 | — |
| +1 | K250417 | Remanufactured EndoWrist Cobra Grasper (420190) | Rebotix | 2025 | — |
| +1 | K250539 | Remanufactured EndoWrist Tenaculum Forceps (420207) | Rebotix | 2025 | — |
| +1 | K250387 | Remanufactured EndoWrist Long Tip Forceps (420048) | Rebotix | 2025 | — |
| +1 | K250399 | Remanufactured EndoWrist Cadiere Forceps (420049) | Rebotix | 2025 | — |
| +1 | K241872 | Remanufactured EndoWrist ProGrasp Forceps (420093) | Rebotix | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 4 | 0 |
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 K232610 da Vinci Surgical System Model IS5000, da…score 32.9 · 24 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K170644 | da Vinci S/Si EndoWrist Instruments and Accessories, Harmonic ACE Curved Shears (5mm &…Summary page 6…Class II, 21 CFR 876.1500 Product Codes NAY Review Panel General and Plastic Surgery Predicate K170644 (Clearance of Reprocessing Instructions for da Vinci S and Si Devices Reusable Instruments)… | 2017 |
| * | K170645 | da Vinci Xi EndoWrist Instruments and AccessoriesSummary page 7…sification Class II, 21 CFR 876.1500 Product Codes NAY, GCJ Review Panel General and Plastic Surgery Predicate Devices K170645 (Clearance of Reprocessing Instructions for da Vinci Xi 8mm Reusable Instruments)… | 2017 |
What descends from it? (6)
6 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K250417 | Remanufactured EndoWrist Cobra Grasper (420190) | 2025 | 0 |
| K250539 | Remanufactured EndoWrist Tenaculum Forceps (420207) | 2025 | 0 |
| K250387 | Remanufactured EndoWrist Long Tip Forceps (420048) | 2025 | 0 |
| K250399 | Remanufactured EndoWrist Cadiere Forceps (420049) | 2025 | 0 |
| K241872 | Remanufactured EndoWrist ProGrasp Forceps (420093) | 2024 | 0 |
| K214095 | da Vinci X/Xi (IS4200/IS4000) 8mm Reusable Instruments | 2022 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All NAY devicesNAY System, Surgical, Computer Controlled Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · NAY
16in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NAY
117in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NAY
1in 2025
Class I (2 since 2007) Class II/III not classified
Adverse event reports per year · NAY
48,456in 2025
MAUDE reports naming product code NAY, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 11 | 133 |
| 2008 | 4 | 189 | 3 | 224 |
| 2009 | 3 | 253 | 1 | 380 |
| 2010 | 1 | — | 0 | 623 |
| 2011 | 7 | 191 | 2 | 501 |
| 2012 | 4 | 106 | 1 | 1,552 |
| 2013 | 4 | 144 | 6 | 6,217 |
| 2014 | 9 | 143 | 25 | 6,135 |
| 2015 | 3 | 99 | 3 | 1,722 |
| 2016 | 8 | 197 | 1 | 1,077 |
| 2017 | 16 | 107 | 1 | 1,049 |
| 2018 | 15 | 152 | 2 | 1,074 |
| 2019 | 8 | 73 | 5 | 1,154 |
| 2020 | 9 | 212 | 0 | 1,558 |
| 2021 | 11 | 61 | 3 | 1,997 |
| 2022 | 6 | 57 | 3 | 5,727 |
| 2023 | 5 | 141 | 2 (1) | 10,898 |
| 2024 | 10 | 126 | 40 | 12,872 |
| 2025 | 16 | 117 | 1 | 48,456 |
| 2026 | 7 | 89 | 4 (1) | — |
What is it indicated for?
The Intuitive Surgical Endoscopic Instrument Control System is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, ultrasonic shears, forceps/pick-ups, needle holders, endoscopic retractors, stabilizers, electrocautery and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection…
Read the full statement (466 words)
The Intuitive Surgical Endoscopic Instrument Control System is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, ultrasonic shears, forceps/pick-ups, needle holders, endoscopic retractors, stabilizers, electrocautery and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, and delivery and placement of microwave and cryogenic ablation probes and accessories, during urologic surgical procedures, general laparoscopic surgical procedures, gynecologic laparoscopic surgical procedures, transoral otolaryngology surgical procedures restricted to benign and malignant tumors classified as TI and T2, and for benign base of tongue resection procedures, general thoracoscopic surgical procedures, and thoracoscopically assisted cardiotomy procedures. The system can also be employed with adjunctive mediastinotomy to perform coronary anastomosis during cardiac revascularization. The system is indicated for adult and pediatric use (except for transoral otolaryngology surgical procedures). It is intended to be used by trained physicians in an operating room environment in accordance with the representative, specific procedures set forth in the Professional Instructions for Use.
The Intuitive Surgical Endoscopic Instrument Control System (da Vinci Surgical System, Model IS4000) is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, 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, suturing, and delivery and placement of microwave and cryogenic ablation probes and accessories, during urologic surgical procedures, general laparoscopic surgical procedures, gynecologic laparoscopic surgical procedures, general thoracoscopic surgical procedures and thoracoscopically-assisted cardiotomy procedures. The system can also be employed with adjunctive mediastinotomy to perform coronary anastomosis during cardiac revascularization. The system is indicated for adult and pediatric use. It is intended to be used by trained physicians in an operating room environment in accordance with the representative, specific procedures set forth in the Professional Instructions for Use.
The Intuitive Surgical Endoscopic Instrument Control System (da Vinci X Surgical System, Model IS4200) is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, 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, suturing, and delivery and placement of microwave and cryogenic ablation probes and accessories, during urologic surgical procedures, general laparoscopic surgical procedures, gynecologic laparoscopic surgical procedures, general thoracoscopic surgical procedures and thoracoscopically-assisted cardiotomy procedures. The system can also be employed with adjunctive mediastinotomy to perform coronary anastomosis during cardiac revascularization. The system is indicated for adult and pediatric use. It is intended to be used 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 as stated in the FDA summary.
https://510kreport.com/device/K203632 · printed Nov 6, 2026
Cite this page
510(k) Report. “K203632: da Vinci S/Si (IS2000/IS3000) 5mm and 8mm Reusable Instruments, da Vinci Xi/X (IS4000/IS4200) 8mm Reusable Instruments.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K203632
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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