510(k) · Cleared
Recalled · Class II · 2022E-100 Electrosurgical Generator, SynchroSeal
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 Nov 14, 2019 as substantially equivalent to K150364 (Erbe Elektromedizin GmbH, 2016) and 1 other predicate after a 185-day review. Its family tree reaches back 18 generations to 1994. 4 later devices descend from it. It has been recalled 2 times.
- Decided
- Nov 14, 2019
- Review
- 185 days
- Class
- Class II
- Product code
- NAY
- Recalls
- 2
- Predicates
- 2
Its longest line of descent runs back 18 generations to K930667 (1994). 107 ancestors in all, the oldest K811390 (1981). 4 later devices descend from it, 1 citing it directly.
- Root · 18 generations backK930667 Reusable Laparoscopic InstrumentsSnowden-Pencer · 1994 · Recalled
- 14 generations between
- 3 generations backK170865 EndoWrist Vessel Sealer, 8 mm Harmonic ACE Curved Shears, da Vinci…Intuitive Surgical, Inc. · 2017
- 2 generations backK173337 Intuitive Surgical EndoWrist Vessel Sealer ExtendIntuitive Surgical, Inc. · 2018 · Recalled
- 1 generation backK183107 Intuitive Surgical Vessel Sealer ExtendIntuitive Surgical, Inc. · 2018
- This deviceK191280 E-100 Electrosurgical Generator, SynchroSealIntuitive Surgical, Inc. · 2019
- Descendant · cites it directly · 3 of its ownK223039 da Vinci E-200 Electrosurgical GeneratorIntuitive Surgical · 2022
- Descendant · 2 generations on · 2 of its ownK231212 da Vinci E-200 Electrosurgical GeneratorIntuitive Surgical · 2023
- Descendant · 3 generations on · 1 of its ownK241635 da Vinci E-200 Electrosurgical GeneratorIntuitive Surgical · 2024
- Descendant · 4 generations on · 0 of its ownK253556 da Vinci SP Surgical System (SP1098); da Vinci E-200 GeneratorIntuitive Surgical, Inc. · 2026
Show all 18 generations
- Root · 18 generations backK930667 Reusable Laparoscopic InstrumentsSnowden-Pencer · 1994 · Recalled
- 17 generations backK960400 Diamond-Touch and Micro Diamond-Touch Instruments/Diamond-Line…Snowden-Pencer · 1996
- 16 generations backK990144 Intuitive Surgical Endoscopic Instruments, Intuitive Surgical…Intuitive Surgical, Inc. · 2000 · Recalled
- 15 generations backK021036 Intuitive Surgical DA Vinci Surgical System, Model IS1000Intuitive Surgical, Inc. · 2002 · Recalled
- 14 generations backK040237 Intuitive Surgical DA Vinci Endoscopic Instrument Control System and…Intuitive Surgical, Inc. · 2004
- 13 generations backK043153 Intuitive Surgical DA Vinci Surgical System and Endoscopic…Intuitive Surgical, Inc. · 2004
- 12 generations backK050005 Intuitive Surgical Monopolar Curved Scissors, Model 400179; Tip…Intuitive Surgical, Inc. · 2005 · Recalled
- 11 generations backK050404 Intuitive Surgical DA Vinci Surgical System and Endoscopic InstrumentsIntuitive Surgical, Inc. · 2005
- 10 generations backK050802 Modification to Intuitive Surgical DA Vinci Surgical System and…Intuitive Surgical, Inc. · 2005
- 9 generations backK063220 DA Vinci S Surgical System-V1.1, Model IS2000Intuitive Surgical, Inc. · 2006 · Recalled
- 8 generations backK081137 Intuitive Surgical DA Vinci SI Surgical System: Model IS3000Intuitive Surgical, Inc. · 2009 · Recalled
- 7 generations backK112208 Intutive Surgical DA Vinci Single Site Instruments and AccessoriesIntuitive Surgical, Inc. · 2011 · Recalled
- 6 generations backK120215 Single-Site Medium-Large Clip Applier, Single-Site Cadiere Grasper…Intuitive Surgical, Inc. · 2012 · Recalled
- 5 generations backK122532 DA Vinci Single-Site Instruments and AccessoriesIntuitive Surgical, Inc. · 2013 · Recalled
- 4 generations backK152448 da Vinci Single-Site Instrument and AccessoriesIntuitive Surgical, Inc. · 2016 · Recalled
- 3 generations backK170865 EndoWrist Vessel Sealer, 8 mm Harmonic ACE Curved Shears, da Vinci…Intuitive Surgical, Inc. · 2017
- 2 generations backK173337 Intuitive Surgical EndoWrist Vessel Sealer ExtendIntuitive Surgical, Inc. · 2018 · Recalled
- 1 generation backK183107 Intuitive Surgical Vessel Sealer ExtendIntuitive Surgical, Inc. · 2018
- This deviceK191280 E-100 Electrosurgical Generator, SynchroSealIntuitive Surgical, Inc. · 2019
Most influential descendants
Showing 4 of 4 · See all- K223039da Vinci E-200 Electrosurgical GeneratorIntuitive Surgical · 2022 · cites it directly3descendants
- K231212da Vinci E-200 Electrosurgical GeneratorIntuitive Surgical · 2023 · 2 generations on2descendants
- K241635da Vinci E-200 Electrosurgical GeneratorIntuitive Surgical · 2024 · 3 generations on1descendant
- K253556da Vinci SP Surgical System (SP1098); da Vinci E-200 GeneratorIntuitive Surgical, Inc. · 2026 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −18 | K930667 | Reusable Laparoscopic Instruments | Snowden-Pencer | 1994 | 15 |
| −17 | K960400 | Diamond-Touch and Micro Diamond-Touch Instruments/Diamond-Line… | Snowden-Pencer | 1996 | — |
| −16 | K990144 | Intuitive Surgical Endoscopic Instruments, Intuitive Surgical Endoscopic… | Intuitive Surgical, Inc. | 2000 | 3 |
| −15 | K021036 | Intuitive Surgical DA Vinci Surgical System, Model IS1000 | Intuitive Surgical, Inc. | 2002 | 18 |
| −14 | K040237 | Intuitive Surgical DA Vinci Endoscopic Instrument Control System and… | Intuitive Surgical, Inc. | 2004 | — |
| −13 | K043153 | Intuitive Surgical DA Vinci Surgical System and Endoscopic Instruments, Models… | Intuitive Surgical, Inc. | 2004 | — |
| −12 | K050005 | Intuitive Surgical Monopolar Curved Scissors, Model 400179; Tip Cover… | Intuitive Surgical, Inc. | 2005 | 2 |
| −11 | K050404 | Intuitive Surgical DA Vinci Surgical System and Endoscopic Instruments | Intuitive Surgical, Inc. | 2005 | — |
| −10 | K050802 | Modification to Intuitive Surgical DA Vinci Surgical System and Endoscopic… | Intuitive Surgical, Inc. | 2005 | — |
| −9 | K063220 | DA Vinci S Surgical System-V1.1, Model IS2000 | Intuitive Surgical, Inc. | 2006 | 4 |
| −8 | K081137 | Intuitive Surgical DA Vinci SI Surgical System: Model IS3000 | Intuitive Surgical, Inc. | 2009 | 25 |
| −7 | K112208 | Intutive Surgical DA Vinci Single Site Instruments and Accessories | Intuitive Surgical, Inc. | 2011 | 12 |
| −6 | K120215 | Single-Site Medium-Large Clip Applier, Single-Site Cadiere Grasper… | Intuitive Surgical, Inc. | 2012 | 3 |
| −5 | K122532 | DA Vinci Single-Site Instruments and Accessories | Intuitive Surgical, Inc. | 2013 | 6 |
| −4 | K152448 | da Vinci Single-Site Instrument and Accessories | Intuitive Surgical, Inc. | 2016 | 1 |
| −3 | K170865 | EndoWrist Vessel Sealer, 8 mm Harmonic ACE Curved Shears, da Vinci Single-Site… | Intuitive Surgical, Inc. | 2017 | — |
| −2 | K173337 | Intuitive Surgical EndoWrist Vessel Sealer Extend | Intuitive Surgical, Inc. | 2018 | 1 |
| −1 | K183107 | Intuitive Surgical Vessel Sealer Extend | Intuitive Surgical, Inc. | 2018 | — |
| 0 (this device) | K191280 | E-100 Electrosurgical Generator, SynchroSeal | Intuitive Surgical, Inc. | 2019 | — |
| +1 | K223039 | da Vinci E-200 Electrosurgical Generator | Intuitive Surgical | 2022 | — |
| +2 | K231212 | da Vinci E-200 Electrosurgical Generator | Intuitive Surgical | 2023 | — |
| +3 | K241635 | da Vinci E-200 Electrosurgical Generator | Intuitive Surgical | 2024 | — |
| +4 | 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 | 4 | 0 |
| 1992 | 4 | 0 |
| 1993 | 3 | 0 |
| 1994 | 8 | 0 |
| 1995 | 10 | 0 |
| 1996 | 2 | 0 |
| 1997 | 6 | 0 |
| 1998 | 4 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 8 | 0 |
| 2002 | 4 | 0 |
| 2003 | 2 | 0 |
| 2004 | 4 | 0 |
| 2005 | 2 | 0 |
| 2006 | 3 | 0 |
| 2007 | 3 | 0 |
| 2008 | 3 | 0 |
| 2009 | 3 | 0 |
| 2010 | 2 | 0 |
| 2011 | 2 | 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 |
|---|---|---|
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 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 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 |
|---|---|---|---|
| * | K150364 | ERBE ESU Model VIO dV with AccessoriesSummary page 6…d Accessories) Secondary: GEI (Electrosurgical, Cutting & Coagulation & Accessories) Predicate Device: Generator: ERBE VIO dV (K150364) Instrument: EndoWrist® Vessel Sealer Extend (K183107) Reference Device: Generator: Just… | 2016 |
| * | K183107 | Intuitive Surgical Vessel Sealer ExtendSummary page 6…g & Coagulation & Accessories) Predicate Device: Generator: ERBE VIO dV (K150364) Instrument: EndoWrist® Vessel Sealer Extend (K183107) Reference Device: Generator: JustRight Surgical Vessel Sealing System (K160602)… | 2018 |
| † | K160602 | JustRight Surgical Vessel Sealing System | 2016 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K223039 | da Vinci E-200 Electrosurgical Generator | 2022 | 3 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 22, 2022 | Class II | Z-1484-2022 | Process design | Due to preventative maintenance (PM) not being performed on E-100 generators which is a bipolar electrosugical unit designed to be used with the da Vinci Xi and X systems. |
| Mar 3, 2022 | Class II | Z-1210-2022 | Use error | Placing excessive tissue in the instrument jaws of the devices prior to sealing and transection can result in an insufficient seal. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 25 years and passes through 2 companies; a new generation was cleared every 1.2 years on median.
- 24 of the 107 ancestors have a recall of any class.
- Of its descendants, K223039 (Intuitive Surgical, 2022) has gone furthest, with 3 descendants of its own.
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. 2019, 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?
SynchroSeal is a bipolar electrosurgical instrument for use with a compatible da Vinci Surgical System and a compatible electrosurgical generator. It is intended for grasping, dissection, sealing and transection of tissue. SynchroSeal can be used to seal vessels up to and including 5 mm in diameter and tissue bundles that fit in the jaws of the instrument. SynchroSeal has not been shown to be effective for tubal sterilization or tubal coagulation for…
Read the full statement (117 words)
SynchroSeal is a bipolar electrosurgical instrument for use with a compatible da Vinci Surgical System and a compatible electrosurgical generator. It is intended for grasping, dissection, sealing and transection of tissue. SynchroSeal can be used to seal vessels up to and including 5 mm in diameter and tissue bundles that fit in the jaws of the instrument. SynchroSeal has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures and should not be used for these procedures.
The E-100 is an electrosurgical generator for use with a compatible da Vinci Surgical System. It is an electrosurgical unit intended to deliver high frequency energy (HF) for cutting, coagulation and vessel sealing of tissues.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K191280 · printed Nov 6, 2026
Cite this page
510(k) Report. “K191280: E-100 Electrosurgical Generator, SynchroSeal.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K191280
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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