510(k) · Cleared
Recalled · Class II · 2012Monopolar Curved Scissors Tip Cover Accessory
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 Oct 7, 2011 as substantially equivalent to K050005 (Intuitive Surgical, Inc., 2005) and 1 other predicate after a 60-day review. Its family tree reaches back 12 generations to 1994. 27 later devices descend from it. It has been recalled once.
- Decided
- Oct 7, 2011
- Review
- 60 days
- Class
- Class II
- Product code
- NAY
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 12 generations to K930667 (1994). 53 ancestors in all, the oldest K811390 (1981). 27 later devices descend from it, 2 citing it directly.
- Root · 12 generations backK930667 Reusable Laparoscopic InstrumentsSnowden-Pencer · 1994 · Recalled
- 8 generations between
- 3 generations backK063220 DA Vinci S Surgical System-V1.1, Model IS2000Intuitive Surgical, Inc. · 2006 · Recalled
- 2 generations backK081137 Intuitive Surgical DA Vinci SI Surgical System: Model IS3000Intuitive Surgical, Inc. · 2009 · Recalled
- 1 generation backK090993 Intuitive Surgical Endoscopic Instrument Control Systems, Models…Intuitive Surgical, Inc. · 2009 · Recalled
- This deviceK112263 Monopolar Curved Scissors Tip Cover AccessoryIntuitive Surgical, Inc. · 2011
- Descendant · cites it directly · 22 of its ownK131962 DA Vinci SP Surgical System, Endowrist SP Instruments, and AccessoriesIntuitive Surgical, Inc. · 2014
- Descendant · 2 generations on · 21 of its ownK173906 da Vinci SP Surgical System, EndoWrist SP Instruments, and AccessoriesIntuitive Surgical, Inc. · 2018 · Recalled
- Descendant · 3 generations on · 20 of its ownK182371 da Vinci SP Surgical System, EndoWrist SP Instruments, and AccessoriesIntuitive Surgical, Inc. · 2019 · Recalled
- Descendant · 4 generations on · 14 of its ownK202571 da Vinci SP Surgical System, Model SP1098, EndoWrist SP Instruments…Intuitive Surgical, Inc. · 2020 · Recalled
- Descendant · 5 generations on · 12 of its ownK230033 Da Vinci SP Surgical System (SP1098)Intuitive Surgical, Inc. · 2023
Show all 12 generations
- Root · 12 generations backK930667 Reusable Laparoscopic InstrumentsSnowden-Pencer · 1994 · Recalled
- 11 generations backK960400 Diamond-Touch and Micro Diamond-Touch Instruments/Diamond-Line…Snowden-Pencer · 1996
- 10 generations backK990144 Intuitive Surgical Endoscopic Instruments, Intuitive Surgical…Intuitive Surgical, Inc. · 2000 · Recalled
- 9 generations backK021036 Intuitive Surgical DA Vinci Surgical System, Model IS1000Intuitive Surgical, Inc. · 2002 · Recalled
- 8 generations backK040237 Intuitive Surgical DA Vinci Endoscopic Instrument Control System and…Intuitive Surgical, Inc. · 2004
- 7 generations backK043153 Intuitive Surgical DA Vinci Surgical System and Endoscopic…Intuitive Surgical, Inc. · 2004
- 6 generations backK050005 Intuitive Surgical Monopolar Curved Scissors, Model 400179; Tip…Intuitive Surgical, Inc. · 2005 · Recalled
- 5 generations backK050404 Intuitive Surgical DA Vinci Surgical System and Endoscopic InstrumentsIntuitive Surgical, Inc. · 2005
- 4 generations backK050802 Modification to Intuitive Surgical DA Vinci Surgical System and…Intuitive Surgical, Inc. · 2005
- 3 generations backK063220 DA Vinci S Surgical System-V1.1, Model IS2000Intuitive Surgical, Inc. · 2006 · Recalled
- 2 generations backK081137 Intuitive Surgical DA Vinci SI Surgical System: Model IS3000Intuitive Surgical, Inc. · 2009 · Recalled
- 1 generation backK090993 Intuitive Surgical Endoscopic Instrument Control Systems, Models…Intuitive Surgical, Inc. · 2009 · Recalled
- This deviceK112263 Monopolar Curved Scissors Tip Cover AccessoryIntuitive Surgical, Inc. · 2011
Showing 5 of 27 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 27 · See all- K131962DA Vinci SP Surgical System, Endowrist SP Instruments, and AccessoriesIntuitive Surgical, Inc. · 2014 · cites it directly22descendants
- K173906da Vinci SP Surgical System, EndoWrist SP Instruments, and AccessoriesIntuitive Surgical, Inc. · 2018 · 2 generations on21descendants
- K182371da Vinci SP Surgical System, EndoWrist SP Instruments, and AccessoriesIntuitive Surgical, Inc. · 2019 · 3 generations on20descendants
- K202571da Vinci SP Surgical System, Model SP1098, EndoWrist SP Instruments, and AccessoriesIntuitive Surgical, Inc. · 2020 · 4 generations on14descendants
- K230033Da Vinci SP Surgical System (SP1098)Intuitive Surgical, Inc. · 2023 · 5 generations on12descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K930667 | Reusable Laparoscopic Instruments | Snowden-Pencer | 1994 | 15 |
| −11 | K960400 | Diamond-Touch and Micro Diamond-Touch Instruments/Diamond-Line… | Snowden-Pencer | 1996 | — |
| −10 | K990144 | Intuitive Surgical Endoscopic Instruments, Intuitive Surgical Endoscopic… | Intuitive Surgical, Inc. | 2000 | 3 |
| −9 | K021036 | Intuitive Surgical DA Vinci Surgical System, Model IS1000 | Intuitive Surgical, Inc. | 2002 | 18 |
| −8 | K040237 | Intuitive Surgical DA Vinci Endoscopic Instrument Control System and… | Intuitive Surgical, Inc. | 2004 | — |
| −7 | K043153 | Intuitive Surgical DA Vinci Surgical System and Endoscopic Instruments, Models… | Intuitive Surgical, Inc. | 2004 | — |
| −6 | K050005 | Intuitive Surgical Monopolar Curved Scissors, Model 400179; Tip Cover… | Intuitive Surgical, Inc. | 2005 | 2 |
| −5 | K050404 | Intuitive Surgical DA Vinci Surgical System and Endoscopic Instruments | Intuitive Surgical, Inc. | 2005 | — |
| −4 | K050802 | Modification to Intuitive Surgical DA Vinci Surgical System and Endoscopic… | Intuitive Surgical, Inc. | 2005 | — |
| −3 | K063220 | DA Vinci S Surgical System-V1.1, Model IS2000 | Intuitive Surgical, Inc. | 2006 | 4 |
| −2 | K081137 | Intuitive Surgical DA Vinci SI Surgical System: Model IS3000 | Intuitive Surgical, Inc. | 2009 | 25 |
| −1 | K090993 | Intuitive Surgical Endoscopic Instrument Control Systems, Models IS1200… | Intuitive Surgical, Inc. | 2009 | 3 |
| 0 (this device) | K112263 | Monopolar Curved Scissors Tip Cover Accessory | Intuitive Surgical, Inc. | 2011 | — |
| +1 | K131962 | DA Vinci SP Surgical System, Endowrist SP Instruments, and Accessories | Intuitive Surgical, Inc. | 2014 | — |
| +2 | K173906 | da Vinci SP Surgical System, EndoWrist SP Instruments, and Accessories | Intuitive Surgical, Inc. | 2018 | 9 |
| +3 | K182371 | da Vinci SP Surgical System, EndoWrist SP Instruments, and Accessories | Intuitive Surgical, Inc. | 2019 | 4 |
| +4 | K202571 | da Vinci SP Surgical System, Model SP1098, EndoWrist SP Instruments, and… | Intuitive Surgical, Inc. | 2020 | 1 |
| +5 | K230033 | Da Vinci SP Surgical System (SP1098) | Intuitive Surgical, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1988 | 1 | 0 |
| 1991 | 3 | 0 |
| 1992 | 1 | 0 |
| 1993 | 2 | 0 |
| 1994 | 2 | 0 |
| 1995 | 2 | 0 |
| 1997 | 7 | 0 |
| 1998 | 2 | 0 |
| 1999 | 3 | 0 |
| 2001 | 5 | 0 |
| 2002 | 3 | 0 |
| 2003 | 1 | 0 |
| 2004 | 4 | 0 |
| 2005 | 2 | 0 |
| 2006 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 3 | 0 |
| 2021 | 3 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 4 | 0 |
| 2025 | 7 | 0 |
| 2026 | 1 | 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 |
|---|---|---|---|
| * | K050005 | Intuitive Surgical Monopolar Curved Scissors, Model 400179; Tip Cover Accessory, Model…Summary page 1…Product Code NAY) Predicate Device: The Monopolar Curved Scissors and Tip Cover Accessory (originally cleared under K050005, current procedures covered under K090993), currently markete… | 2005 |
| * | K090993 | Intuitive Surgical Endoscopic Instrument Control Systems, Models IS1200, IS2000 and IS3000Summary page 1…Scissors and Tip Cover Accessory (originally cleared under K050005, current procedures covered under K090993), currently marketed by Intuitive Surgical, Inc. (Sunnyvale, CA). Device Description:… | 2009 |
What descends from it? (27)
See all 272 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 9, 2012 | Class II | Z-2339-2012 | Employee error | There is potential for the sterility of the product to be compromised. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 17 years and passes through 2 companies; a new generation was cleared every 1.8 years on median.
- 12 of the 53 ancestors have a recall of any class.
- Of its descendants, K131962 (Intuitive Surgical, Inc., 2014) has gone furthest, with 22 descendants of its own.
- 6 other devices also cite its predicate K050005.
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. 2011, 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 Systems (da Vinci, da Vinci S and da Vinci Si Surgical Systems Models 1S1200, 1S2000, IS3000) are intended to assist in the accurate control of Intuitive Surgical Endloscopic EndloWrist Instruments and Accessories including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, ultrasonic/harmonic shears; forceps/pick-ups, needle holders, endoscopic retractors, stabilizers…
Read the full statement (180 words)
The Intuitive Surgical Endoscopic Instrument Control Systems (da Vinci, da Vinci S and da Vinci Si Surgical Systems Models 1S1200, 1S2000, IS3000) are intended to assist in the accurate control of Intuitive Surgical Endloscopic EndloWrist Instruments and Accessories including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, ultrasonic/harmonic 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, delivery and placement of microwave and cryogenic ablation probes and accessories, during urologic surgical procedures, general laparoscopic surgical procedures, gynecological laparoscopic surgical procedures, transoral otolaryngology surgical procedures restricted to benign and malignant tumors classified as Ti and T2, 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 Instructions for Use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K112263 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112263: Monopolar Curved Scissors Tip Cover Accessory.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112263
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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