510(k) · Cleared
ClearedElectrosurgical Unit (Esu) (115 Volt) Model 4810, Electrosurgical Unit (Esu) (230 Volt) Model 4811, Instrument Cable, 19
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific Corp · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Sep 3, 1998 after a 90-day review. The FDA summary names its predicate without a number. 47 later devices descend from it.
- Decided
- Sep 3, 1998
- Review
- 90 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 0
47 later devices descend from it, 5 citing it directly.
- This deviceK981981 Electrosurgical Unit (Esu) (115 Volt) Model 4810, Electrosurgical…Boston Scientific Corp · 1998
- Descendant · cites it directly · 25 of its ownK022008 Cardima Ablation SystemCardima, Inc. · 2003 · Recalled
- Descendant · cites it directly · 25 of its ownK023291 Cobra Cooled Cardiac Surgical Probe, Model 1596XBoston Scientific Corp · 2002
- Descendant · 2 generations on · 23 of its ownK022894 Epicor Medical Ablation SystemEpicor Medical, Inc. · 2004
- Descendant · 2 generations on · 22 of its ownK040641 Ultracinch Ablation Device, Ultracinch Accessory Pack, Models UC-8…Epicor Medical, Inc. · 2004
- Descendant · cites it directly · 19 of its ownK051749 Cobra Surgical SystemEstech, Inc. · 2005
Showing 5 of 47 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 47 · See all- K022008Cardima Ablation SystemCardima, Inc. · 2003 · cites it directly25descendants
- K023291Cobra Cooled Cardiac Surgical Probe, Model 1596XBoston Scientific Corp · 2002 · cites it directly25descendants
- K022894Epicor Medical Ablation SystemEpicor Medical, Inc. · 2004 · 2 generations on23descendants
- K040641Ultracinch Ablation Device, Ultracinch Accessory Pack, Models UC-8, UC-9, UC-10, UC-11…Epicor Medical, Inc. · 2004 · 2 generations on22descendants
- K051749Cobra Surgical SystemEstech, Inc. · 2005 · cites it directly19descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K981981 | Electrosurgical Unit (Esu) (115 Volt) Model 4810, Electrosurgical Unit (Esu)… | Boston Scientific Corp | 1998 | — |
| +1 | K022008 | Cardima Ablation System | Cardima, Inc. | 2003 | 2 |
| +1 | K023291 | Cobra Cooled Cardiac Surgical Probe, Model 1596X | Boston Scientific Corp | 2002 | — |
| +2 | K022894 | Epicor Medical Ablation System | Epicor Medical, Inc. | 2004 | — |
| +2 | K040641 | Ultracinch Ablation Device, Ultracinch Accessory Pack, Models UC-8, UC-9… | Epicor Medical, Inc. | 2004 | — |
| +1 | K051749 | Cobra Surgical System | Estech, Inc. | 2005 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 3 | 0 |
| 2005 | 1 | 0 |
| 2006 | 5 | 0 |
| 2007 | 2 | 0 |
| 2008 | 3 | 0 |
| 2009 | 1 | 0 |
| 2010 | 3 | 0 |
| 2011 | 2 | 0 |
| 2012 | 4 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 3 | 0 |
| 2018 | 1 | 0 |
| 2019 | 5 | 0 |
| 2020 | 1 | 0 |
| 2021 | 2 | 0 |
| 2022 | 2 | 0 |
| 2024 | 2 | 0 |
| 2025 | 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? (8)
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 |
|---|---|---|---|
| * | — | Valley Lab Force 40 Named without a submission number | |
| * | — | VNUS Medical Closure™ System Named without a submission number | |
| * | — | Somnus Medical Model 615 Named without a submission number | |
| * | — | Oratec ORA-50™ Named without a submission number | |
| * | — | Arthrocare Electrosurgery System Named without a submission number | |
| * | — | Wappler Electrosurgical Unit Named without a submission number | |
| * | — | Ximed Medical Electrode Probe Named without a submission number | |
| * | — | Circon Surgical Instruments Named without a submission number |
What descends from it? (47)
See all 475 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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K022008 (Cardima, Inc., 2003) has gone furthest, with 25 descendants 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.
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 Boston Scientific Tissue Coagulation System is intended for use only under direct visual control of the physician during open, general surgical procedures to coagulate soft tissues. The Tissue Coagulation System may also be used to coagulate blood and soft tissues to produce hemostasis.
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/K981981 · printed Nov 4, 2026
Cite this page
510(k) Report. “K981981: Electrosurgical Unit (Esu) (115 Volt) Model 4810, Electrosurgical Unit (Esu) (230 Volt) Model 4811, Instrument Cable, 19.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K981981
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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