510(k) · Decided
Recalled · Class II · 2015DA Vinci Single-Site Permanent Cautery Hook
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 Jun 7, 2013 as substantially equivalent to K112208 (Intuitive Surgical, Inc., 2011) and 1 other predicate after an 81-day review. Its family tree reaches back 13 generations to 1994. 2 later devices descend from it. It has been recalled 7 times.
- Decided
- Jun 7, 2013
- Review
- 81 days
- Class
- Class II
- Product code
- NAY
- Recalls
- 7
- Predicates
- 3
Its longest line of descent runs back 13 generations to K930667 (1994). 74 ancestors in all, the oldest K811390 (1981). 2 later devices descend from it, 2 citing it directly.
- Root · 13 generations backK930667 Reusable Laparoscopic InstrumentsSnowden-Pencer · 1994 · Recalled
- 9 generations between
- 3 generations backK081137 Intuitive Surgical DA Vinci SI Surgical System: Model IS3000Intuitive Surgical, Inc. · 2009 · Recalled
- 2 generations backK112208 Intutive Surgical DA Vinci Single Site Instruments and AccessoriesIntuitive Surgical, Inc. · 2011 · Recalled
- 1 generation backK120215 Single-Site Medium-Large Clip Applier, Single-Site Cadiere Grasper…Intuitive Surgical, Inc. · 2012 · Recalled
- This deviceK130726 DA Vinci Single-Site Permanent Cautery HookIntuitive Surgical, Inc. · 2013
- Descendant · cites it directly · 0 of its ownK170875 da Vinci Si Single-Site Instruments and Accessories, da Vinci Xi…Intuitive Surgical, Inc. · 2017
- Descendant · cites it directly · 0 of its ownK133203 Single-Site PortIntuitive Surgical, Inc. · 2014
Show all 13 generations
- Root · 13 generations backK930667 Reusable Laparoscopic InstrumentsSnowden-Pencer · 1994 · Recalled
- 12 generations backK960400 Diamond-Touch and Micro Diamond-Touch Instruments/Diamond-Line…Snowden-Pencer · 1996
- 11 generations backK990144 Intuitive Surgical Endoscopic Instruments, Intuitive Surgical…Intuitive Surgical, Inc. · 2000 · Recalled
- 10 generations backK021036 Intuitive Surgical DA Vinci Surgical System, Model IS1000Intuitive Surgical, Inc. · 2002 · Recalled
- 9 generations backK040237 Intuitive Surgical DA Vinci Endoscopic Instrument Control System and…Intuitive Surgical, Inc. · 2004
- 8 generations backK043153 Intuitive Surgical DA Vinci Surgical System and Endoscopic…Intuitive Surgical, Inc. · 2004
- 7 generations backK050005 Intuitive Surgical Monopolar Curved Scissors, Model 400179; Tip…Intuitive Surgical, Inc. · 2005 · Recalled
- 6 generations backK050404 Intuitive Surgical DA Vinci Surgical System and Endoscopic InstrumentsIntuitive Surgical, Inc. · 2005
- 5 generations backK050802 Modification to Intuitive Surgical DA Vinci Surgical System and…Intuitive Surgical, Inc. · 2005
- 4 generations backK063220 DA Vinci S Surgical System-V1.1, Model IS2000Intuitive Surgical, Inc. · 2006 · Recalled
- 3 generations backK081137 Intuitive Surgical DA Vinci SI Surgical System: Model IS3000Intuitive Surgical, Inc. · 2009 · Recalled
- 2 generations backK112208 Intutive Surgical DA Vinci Single Site Instruments and AccessoriesIntuitive Surgical, Inc. · 2011 · Recalled
- 1 generation backK120215 Single-Site Medium-Large Clip Applier, Single-Site Cadiere Grasper…Intuitive Surgical, Inc. · 2012 · Recalled
- This deviceK130726 DA Vinci Single-Site Permanent Cautery HookIntuitive Surgical, Inc. · 2013
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K930667 | Reusable Laparoscopic Instruments | Snowden-Pencer | 1994 | 15 |
| −12 | K960400 | Diamond-Touch and Micro Diamond-Touch Instruments/Diamond-Line… | Snowden-Pencer | 1996 | — |
| −11 | K990144 | Intuitive Surgical Endoscopic Instruments, Intuitive Surgical Endoscopic… | Intuitive Surgical, Inc. | 2000 | 3 |
| −10 | K021036 | Intuitive Surgical DA Vinci Surgical System, Model IS1000 | Intuitive Surgical, Inc. | 2002 | 18 |
| −9 | K040237 | Intuitive Surgical DA Vinci Endoscopic Instrument Control System and… | Intuitive Surgical, Inc. | 2004 | — |
| −8 | K043153 | Intuitive Surgical DA Vinci Surgical System and Endoscopic Instruments, Models… | Intuitive Surgical, Inc. | 2004 | — |
| −7 | K050005 | Intuitive Surgical Monopolar Curved Scissors, Model 400179; Tip Cover… | Intuitive Surgical, Inc. | 2005 | 2 |
| −6 | K050404 | Intuitive Surgical DA Vinci Surgical System and Endoscopic Instruments | Intuitive Surgical, Inc. | 2005 | — |
| −5 | K050802 | Modification to Intuitive Surgical DA Vinci Surgical System and Endoscopic… | Intuitive Surgical, Inc. | 2005 | — |
| −4 | K063220 | DA Vinci S Surgical System-V1.1, Model IS2000 | Intuitive Surgical, Inc. | 2006 | 4 |
| −3 | K081137 | Intuitive Surgical DA Vinci SI Surgical System: Model IS3000 | Intuitive Surgical, Inc. | 2009 | 25 |
| −2 | K112208 | Intutive Surgical DA Vinci Single Site Instruments and Accessories | Intuitive Surgical, Inc. | 2011 | 12 |
| −1 | K120215 | Single-Site Medium-Large Clip Applier, Single-Site Cadiere Grasper… | Intuitive Surgical, Inc. | 2012 | 3 |
| 0 (this device) | K130726 | DA Vinci Single-Site Permanent Cautery Hook | Intuitive Surgical, Inc. | 2013 | — |
| +1 | K170875 | da Vinci Si Single-Site Instruments and Accessories, da Vinci Xi Single-Site… | Intuitive Surgical, Inc. | 2017 | — |
| +1 | K133203 | Single-Site Port | Intuitive Surgical, Inc. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1988 | 2 | 0 |
| 1991 | 3 | 0 |
| 1992 | 3 | 0 |
| 1993 | 3 | 0 |
| 1994 | 6 | 0 |
| 1995 | 6 | 0 |
| 1996 | 1 | 0 |
| 1997 | 6 | 0 |
| 1998 | 3 | 0 |
| 1999 | 2 | 0 |
| 2001 | 8 | 0 |
| 2002 | 3 | 0 |
| 2003 | 1 | 0 |
| 2004 | 3 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 2 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2017 | 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? (3)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K112208 | Intutive Surgical DA Vinci Single Site Instruments and AccessoriesSummary page 1…Code: NAY, GCIJ Classification: Endoscope and Accessories, 21 CFR 876.1500 Predicate Devices: o Intuitive Surgical® da Vincig Single-Site™ Instruments and Accessories (K112208/K120215/K122532) Device Description: The da Vinci Single-Site Instruments and Accessorics consist of semi-rigid shaft instrumen… | 2011 |
| * | K120215 | Single-Site Medium-Large Clip Applier, Single-Site Cadiere Grasper, Single-Site Fundus…Summary page 1…Y, GCIJ Classification: Endoscope and Accessories, 21 CFR 876.1500 Predicate Devices: o Intuitive Surgical® da Vincig Single-Site™ Instruments and Accessories (K112208/K120215/K122532) Device Description: The da Vinci Single-Site Instruments and Accessorics consist of semi-rigid shaft instruments, two… | 2012 |
| Kept off the family tree | K122532 | FDA’s K122532 is DA Vinci Single-Site Instruments and Accessories Our OCR of the scanned summary read K122532, which FDA decided on Jul 30, 2013, after this device was decided (Jun 7, 2013), so it cannot be the predicate: a misreading, the summary’s own error, or a submission still pending at the time. Kept off the family tree. Summary page 1…Classification: Endoscope and Accessories, 21 CFR 876.1500 Predicate Devices: o Intuitive Surgical® da Vincig Single-Site™ Instruments and Accessories (K112208/K120215/K122532) Device Description: The da Vinci Single-Site Instruments and Accessorics consist of semi-rigid shaft instruments, two fixed-sh… | 2013 |
What descends from it? (2)
2 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 8, 2015 | Class II | Z-2756-2015 | Device Design | In certain circumstances involving select da Vinci Si Single-Site instruments, the jaws of grip actuated instruments may become fixed in a closed position. |
| Aug 8, 2015 | Class II | Z-2757-2015 | Device Design | In certain circumstances involving select da Vinci Si Single-Site instruments, the jaws of grip actuated instruments may become fixed in a closed position. |
| Aug 8, 2015 | Class II | Z-2752-2015 | Device Design | In certain circumstances involving select da Vinci Si Single-Site instruments, the jaws of grip actuated instruments may become fixed in a closed position. |
| Aug 8, 2015 | Class II | Z-2753-2015 | Device Design | In certain circumstances involving select da Vinci Si Single-Site instruments, the jaws of grip actuated instruments may become fixed in a closed position. |
| Aug 8, 2015 | Class II | Z-2750-2015 | Device Design | In certain circumstances involving select da Vinci Si Single-Site instruments, the jaws of grip actuated instruments may become fixed in a closed position. |
| Aug 8, 2015 | Class II | Z-2751-2015 | Device Design | In certain circumstances involving select da Vinci Si Single-Site instruments, the jaws of grip actuated instruments may become fixed in a closed position. |
| Aug 8, 2015 | Class II | Z-2758-2015 | Device Design | In certain circumstances involving select da Vinci Si Single-Site instruments, the jaws of grip actuated instruments may become fixed in a closed position. |
The 5 latest of 7 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 19 years and passes through 2 companies; a new generation was cleared every 1.4 years on median.
- 15 of the 74 ancestors have a recall of any class.
- Of its descendants, K170875 (Intuitive Surgical, Inc., 2017) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K112208.
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. 2013, 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® da Vinci® Single-Site™ Instruments and Accessories used with the da Vinci® Si Surgical System (IS3000) are indicated for use by trained physicians in an operating room environment for endoscopic manipulation of tissue, grasping, cutting, blunt and sharp dissection, approximation, clip-ligation, electrocautery and suturing during single incision laparoscopic cholecystectomy, benign hysterectomy and salpingo-oophorectomy with the da…
Read the full statement (95 words)
The Intuitive Surgical® da Vinci® Single-Site™ Instruments and Accessories used with the da Vinci® Si Surgical System (IS3000) are indicated for use by trained physicians in an operating room environment for endoscopic manipulation of tissue, grasping, cutting, blunt and sharp dissection, approximation, clip-ligation, electrocautery and suturing during single incision laparoscopic cholecystectomy, benign hysterectomy and salpingo-oophorectomy with the da Vinci Single-Site Instruments and Accessories, including graspers, dissectors, needle drivers, scissors, suction irrigators, monopolar cautery, bipolar cautery, 5 mm curved cannulae, 5 mm and 10 mm straight cannulae, flexible blunt obturators, and the 5 mm Single-Site Port.
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/K130726 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130726: DA Vinci Single-Site Permanent Cautery Hook.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130726
Report an extraction error
Are you the manufacturer?
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