510(k) · Cleared
Clearedda Vinci E-200 Electrosurgical Generator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Intuitive Surgical · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Jun 21, 2023 as substantially equivalent to K223039 (Intuitive Surgical, 2022) after a 54-day review. Its family tree reaches back 20 generations to 1994. 2 later devices descend from it.
- Decided
- Jun 21, 2023
- Review
- 54 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 20 generations to K930667 (1994). 128 ancestors in all, the oldest K811390 (1981). 2 later devices descend from it, 1 citing it directly.
- Root · 20 generations backK930667 Reusable Laparoscopic InstrumentsSnowden-Pencer · 1994 · Recalled
- 16 generations between
- 3 generations backK183107 Intuitive Surgical Vessel Sealer ExtendIntuitive Surgical, Inc. · 2018
- 2 generations backK191280 E-100 Electrosurgical Generator, SynchroSealIntuitive Surgical, Inc. · 2019 · Recalled
- 1 generation backK223039 da Vinci E-200 Electrosurgical GeneratorIntuitive Surgical · 2022
- This deviceK231212 da Vinci E-200 Electrosurgical GeneratorIntuitive Surgical · 2023
- Descendant · cites it directly · 1 of its ownK241635 da Vinci E-200 Electrosurgical GeneratorIntuitive Surgical · 2024
- Descendant · 2 generations on · 0 of its ownK253556 da Vinci SP Surgical System (SP1098); da Vinci E-200 GeneratorIntuitive Surgical, Inc. · 2026
Show all 20 generations
- Root · 20 generations backK930667 Reusable Laparoscopic InstrumentsSnowden-Pencer · 1994 · Recalled
- 19 generations backK960400 Diamond-Touch and Micro Diamond-Touch Instruments/Diamond-Line…Snowden-Pencer · 1996
- 18 generations backK990144 Intuitive Surgical Endoscopic Instruments, Intuitive Surgical…Intuitive Surgical, Inc. · 2000 · Recalled
- 17 generations backK021036 Intuitive Surgical DA Vinci Surgical System, Model IS1000Intuitive Surgical, Inc. · 2002 · Recalled
- 16 generations backK040237 Intuitive Surgical DA Vinci Endoscopic Instrument Control System and…Intuitive Surgical, Inc. · 2004
- 15 generations backK043153 Intuitive Surgical DA Vinci Surgical System and Endoscopic…Intuitive Surgical, Inc. · 2004
- 14 generations backK050005 Intuitive Surgical Monopolar Curved Scissors, Model 400179; Tip…Intuitive Surgical, Inc. · 2005 · Recalled
- 13 generations backK050404 Intuitive Surgical DA Vinci Surgical System and Endoscopic InstrumentsIntuitive Surgical, Inc. · 2005
- 12 generations backK050802 Modification to Intuitive Surgical DA Vinci Surgical System and…Intuitive Surgical, Inc. · 2005
- 11 generations backK063220 DA Vinci S Surgical System-V1.1, Model IS2000Intuitive Surgical, Inc. · 2006 · Recalled
- 10 generations backK081137 Intuitive Surgical DA Vinci SI Surgical System: Model IS3000Intuitive Surgical, Inc. · 2009 · Recalled
- 9 generations backK112208 Intutive Surgical DA Vinci Single Site Instruments and AccessoriesIntuitive Surgical, Inc. · 2011 · Recalled
- 8 generations backK120215 Single-Site Medium-Large Clip Applier, Single-Site Cadiere Grasper…Intuitive Surgical, Inc. · 2012 · Recalled
- 7 generations backK122532 DA Vinci Single-Site Instruments and AccessoriesIntuitive Surgical, Inc. · 2013 · Recalled
- 6 generations backK152448 da Vinci Single-Site Instrument and AccessoriesIntuitive Surgical, Inc. · 2016 · Recalled
- 5 generations backK170865 EndoWrist Vessel Sealer, 8 mm Harmonic ACE Curved Shears, da Vinci…Intuitive Surgical, Inc. · 2017
- 4 generations backK173337 Intuitive Surgical EndoWrist Vessel Sealer ExtendIntuitive Surgical, Inc. · 2018 · Recalled
- 3 generations backK183107 Intuitive Surgical Vessel Sealer ExtendIntuitive Surgical, Inc. · 2018
- 2 generations backK191280 E-100 Electrosurgical Generator, SynchroSealIntuitive Surgical, Inc. · 2019 · Recalled
- 1 generation backK223039 da Vinci E-200 Electrosurgical GeneratorIntuitive Surgical · 2022
- This deviceK231212 da Vinci E-200 Electrosurgical GeneratorIntuitive Surgical · 2023
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 |
|---|---|---|---|---|---|
| −20 | K930667 | Reusable Laparoscopic Instruments | Snowden-Pencer | 1994 | 15 |
| −19 | K960400 | Diamond-Touch and Micro Diamond-Touch Instruments/Diamond-Line… | Snowden-Pencer | 1996 | — |
| −18 | K990144 | Intuitive Surgical Endoscopic Instruments, Intuitive Surgical Endoscopic… | Intuitive Surgical, Inc. | 2000 | 3 |
| −17 | K021036 | Intuitive Surgical DA Vinci Surgical System, Model IS1000 | Intuitive Surgical, Inc. | 2002 | 18 |
| −16 | K040237 | Intuitive Surgical DA Vinci Endoscopic Instrument Control System and… | Intuitive Surgical, Inc. | 2004 | — |
| −15 | K043153 | Intuitive Surgical DA Vinci Surgical System and Endoscopic Instruments, Models… | Intuitive Surgical, Inc. | 2004 | — |
| −14 | K050005 | Intuitive Surgical Monopolar Curved Scissors, Model 400179; Tip Cover… | Intuitive Surgical, Inc. | 2005 | 2 |
| −13 | K050404 | Intuitive Surgical DA Vinci Surgical System and Endoscopic Instruments | Intuitive Surgical, Inc. | 2005 | — |
| −12 | K050802 | Modification to Intuitive Surgical DA Vinci Surgical System and Endoscopic… | Intuitive Surgical, Inc. | 2005 | — |
| −11 | K063220 | DA Vinci S Surgical System-V1.1, Model IS2000 | Intuitive Surgical, Inc. | 2006 | 4 |
| −10 | K081137 | Intuitive Surgical DA Vinci SI Surgical System: Model IS3000 | Intuitive Surgical, Inc. | 2009 | 25 |
| −9 | K112208 | Intutive Surgical DA Vinci Single Site Instruments and Accessories | Intuitive Surgical, Inc. | 2011 | 12 |
| −8 | K120215 | Single-Site Medium-Large Clip Applier, Single-Site Cadiere Grasper… | Intuitive Surgical, Inc. | 2012 | 3 |
| −7 | K122532 | DA Vinci Single-Site Instruments and Accessories | Intuitive Surgical, Inc. | 2013 | 6 |
| −6 | K152448 | da Vinci Single-Site Instrument and Accessories | Intuitive Surgical, Inc. | 2016 | 1 |
| −5 | K170865 | EndoWrist Vessel Sealer, 8 mm Harmonic ACE Curved Shears, da Vinci Single-Site… | Intuitive Surgical, Inc. | 2017 | — |
| −4 | K173337 | Intuitive Surgical EndoWrist Vessel Sealer Extend | Intuitive Surgical, Inc. | 2018 | 1 |
| −3 | K183107 | Intuitive Surgical Vessel Sealer Extend | Intuitive Surgical, Inc. | 2018 | — |
| −2 | K191280 | E-100 Electrosurgical Generator, SynchroSeal | Intuitive Surgical, Inc. | 2019 | 2 |
| −1 | K223039 | da Vinci E-200 Electrosurgical Generator | Intuitive Surgical | 2022 | — |
| 0 (this device) | K231212 | da Vinci E-200 Electrosurgical Generator | Intuitive Surgical | 2023 | — |
| +1 | K241635 | da Vinci E-200 Electrosurgical Generator | Intuitive Surgical | 2024 | — |
| +2 | K253556 | da Vinci SP Surgical System (SP1098); da Vinci E-200 Generator | Intuitive Surgical, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1988 | 2 | 0 |
| 1990 | 1 | 0 |
| 1991 | 5 | 0 |
| 1992 | 4 | 0 |
| 1993 | 3 | 0 |
| 1994 | 8 | 0 |
| 1995 | 10 | 0 |
| 1996 | 3 | 0 |
| 1997 | 8 | 0 |
| 1998 | 4 | 0 |
| 1999 | 5 | 0 |
| 2000 | 4 | 0 |
| 2001 | 8 | 0 |
| 2002 | 5 | 0 |
| 2003 | 4 | 0 |
| 2004 | 4 | 0 |
| 2005 | 3 | 0 |
| 2006 | 3 | 0 |
| 2007 | 5 | 0 |
| 2008 | 4 | 0 |
| 2009 | 3 | 0 |
| 2010 | 3 | 0 |
| 2011 | 3 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 1 | 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 GEI? 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 GEI device
- #1 K231790 The InMode System with the Morpheus8 Applicatorsscore 32.7 · 21 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 |
|---|---|---|---|
| * | K223039 | da Vinci E-200 Electrosurgical GeneratorSummary page 4…accessories. Product Code: GEI (Electrosurgical, Cutting & Coagulation & Accessories) Predicate Device: da Vinci E-200 Electrosurgical Generator (K223039) Reference Device: Valleylab™ FT-10 Energy Platform (K151649) Device Description: 7KHGD9LQFL(ဨLVDQHOHFWURVXUJLFDOXQ… | 2022 |
| † | K151649 | Valleylab FT10 Electrosurgical Platform | 2015 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K241635 | da Vinci E-200 Electrosurgical Generator | 2024 | 1 |
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?
- The line of descent spans 29 years and passes through 3 companies; a new generation was cleared every 1.2 years on median.
- 27 of the 128 ancestors have a recall of any class.
- Of its descendants, K241635 (Intuitive Surgical, 2024) has gone furthest, with 1 descendant of its own.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · GEI
52in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GEI
113in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GEI
4in 2025
Class I (14 since 2007) Class II/III not classified
Adverse event reports per year · GEI
7,592in 2025
MAUDE reports naming product code GEI, 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 | 50 | 51 | 21 | 2,795 |
| 2008 | 61 | 71 | 19 | 2,556 |
| 2009 | 42 | 130 | 27 | 3,591 |
| 2010 | 46 | 109 | 51 | 3,377 |
| 2011 | 35 | 135 | 32 | 4,463 |
| 2012 | 39 | 133 | 30 | 5,216 |
| 2013 | 48 | 136 | 13 | 4,897 |
| 2014 | 49 | 103 | 3 | 4,908 |
| 2015 | 47 | 123 | 4 | 4,936 |
| 2016 | 64 | 108 | 3 | 5,616 |
| 2017 | 52 | 72 | 2 | 6,073 |
| 2018 | 47 | 93 | 6 | 6,545 |
| 2019 | 48 | 93 | 5 | 7,067 |
| 2020 | 59 | 105 | 1 | 6,490 |
| 2021 | 46 | 146 | 6 | 6,354 |
| 2022 | 55 | 150 | 49 | 6,103 |
| 2023 | 65 | 104 | 27 (4) | 7,176 |
| 2024 | 59 | 125 | 22 (10) | 7,897 |
| 2025 | 52 | 113 | 4 | 7,592 |
| 2026 | 43 | 183 | 8 | — |
What is it indicated for?
The da Vinci E-200 Electrosurgical Generator is intended to deliver high-frequency energy for cutting, coagulation and vessel sealing of tissues in da Vinci robotic procedures, and non-robotic open and laparoscopic procedures.
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/K231212 · printed Nov 6, 2026
Cite this page
510(k) Report. “K231212: da Vinci E-200 Electrosurgical Generator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K231212
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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