510(k) · Cleared
Recalled · Class II · 20258mm Monopolar Curved Scissors
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 Apr 6, 2018 as substantially equivalent to K050369 (Intuitive Surgical, Inc., 2005) after a 92-day review. Its family tree reaches back 7 generations to 1994. 1 later device descends from it. It has been recalled 2 times.
- Decided
- Apr 6, 2018
- Review
- 92 days
- Class
- Class II
- Product code
- NAY
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 7 generations to K930667 (1994). 28 ancestors in all, the oldest K811390 (1981). 1 later device descends from it, 1 citing it directly.
- Root · 7 generations backK930667 Reusable Laparoscopic InstrumentsSnowden-Pencer · 1994 · Recalled
- 6 generations backK960400 Diamond-Touch and Micro Diamond-Touch Instruments/Diamond-Line…Snowden-Pencer · 1996
- 5 generations backK990144 Intuitive Surgical Endoscopic Instruments, Intuitive Surgical…Intuitive Surgical, Inc. · 2000 · Recalled
- 4 generations backK021036 Intuitive Surgical DA Vinci Surgical System, Model IS1000Intuitive Surgical, Inc. · 2002 · Recalled
- 3 generations backK040237 Intuitive Surgical DA Vinci Endoscopic Instrument Control System and…Intuitive Surgical, Inc. · 2004
- 2 generations backK043153 Intuitive Surgical DA Vinci Surgical System and Endoscopic…Intuitive Surgical, Inc. · 2004
- 1 generation backK050369 Intuitive Surgical DA Vinci Surgical System, Model IS2000Intuitive Surgical, Inc. · 2005 · Recalled
- This deviceK180033 8mm Monopolar Curved ScissorsIntuitive Surgical, Inc. · 2018
- Descendant · cites it directly · 0 of its ownK210478 8mm Monopolar Curved ScissorsIconocare Health · 2022
Most influential descendants
Showing 1 of 1 · See all- K2104788mm Monopolar Curved ScissorsIconocare Health · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K930667 | Reusable Laparoscopic Instruments | Snowden-Pencer | 1994 | 15 |
| −6 | K960400 | Diamond-Touch and Micro Diamond-Touch Instruments/Diamond-Line… | Snowden-Pencer | 1996 | — |
| −5 | K990144 | Intuitive Surgical Endoscopic Instruments, Intuitive Surgical Endoscopic… | Intuitive Surgical, Inc. | 2000 | 3 |
| −4 | K021036 | Intuitive Surgical DA Vinci Surgical System, Model IS1000 | Intuitive Surgical, Inc. | 2002 | 18 |
| −3 | K040237 | Intuitive Surgical DA Vinci Endoscopic Instrument Control System and… | Intuitive Surgical, Inc. | 2004 | — |
| −2 | K043153 | Intuitive Surgical DA Vinci Surgical System and Endoscopic Instruments, Models… | Intuitive Surgical, Inc. | 2004 | — |
| −1 | K050369 | Intuitive Surgical DA Vinci Surgical System, Model IS2000 | Intuitive Surgical, Inc. | 2005 | 51 |
| 0 (this device) | K180033 | 8mm Monopolar Curved Scissors | Intuitive Surgical, Inc. | 2018 | — |
| +1 | K210478 | 8mm Monopolar Curved Scissors | Iconocare Health | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1988 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 2 | 0 |
| 1997 | 4 | 0 |
| 1998 | 1 | 0 |
| 2001 | 3 | 0 |
| 2002 | 3 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K050369 | Intuitive Surgical DA Vinci Surgical System, Model IS2000Summary page 4…876.1500, Endoscope and Accessories Product Codes: NAY Classification Advisory General and Plastic Surgery Committee: Predicate Device: K050369 (use with the IS2000 system), with additional indications under K081137 (use with the IS3000 system… | 2005 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K210478 | 8mm Monopolar Curved Scissors | 2022 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 9, 2025 | Class II | Z-1696-2026 | Process control | Due to increased complaints for broken/frayed grip cables for reusable instruments. |
| Aug 15, 2018 | Class II | Z-3024-2018 | Use error | Monopolar Curved Scissor (MCS) instruments may be susceptible to developing cracks near the proximal edge of the extension tube. These cracks may fracture the plastic surrounding the instrument shaft, and may cause fragments of the… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 24 years and passes through 2 companies; a new generation was cleared every 2.0 years on median.
- 4 of the 28 ancestors have a recall of any class.
- Of its descendants, K210478 (Iconocare Health, 2022) has gone furthest, with 0 descendants of its own.
- 19 other devices also cite its predicate K050369.
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. 2018, 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 (175 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 robotic surgical procedures restricted to benign and malignant tumors classified as TT 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 robotic 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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K180033 · printed Nov 6, 2026
Cite this page
510(k) Report. “K180033: 8mm Monopolar Curved Scissors.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K180033
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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