510(k) · Cleared
ClearedSurgitron Iec II
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ellman Intl., Inc. · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Jul 24, 2000 after an 81-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 5 later devices descend from it.
- Decided
- Jul 24, 2000
- Review
- 81 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 3 citing it directly.
- This deviceK001407 Surgitron Iec IIEllman Intl., Inc. · 2000
- Descendant · cites it directly · 2 of its ownK012799 ES-2000 Shape Select Electrosurgical ScalpelSenorx, Inc. · 2001
- Descendant · 2 generations on · 0 of its ownK070275 Flexible Loop Electrosurgical ElectrodeRubicor Medical, Inc. · 2007
- Descendant · cites it directly · 0 of its ownK030473 Senorx ES-300Senorx, Inc. · 2003
- Descendant · 2 generations on · 0 of its ownK021707 Single Step Biopsy Device, Single Step Surgical Handle, Single Step…Senorx, Inc. · 2002
- Descendant · cites it directly · 0 of its ownK012129 Ortho Development Orion-I Emf SystemOrtho Development Corp. · 2001
Most influential descendants
Showing 5 of 5 · See all- K012799ES-2000 Shape Select Electrosurgical ScalpelSenorx, Inc. · 2001 · cites it directly2descendants
- K070275Flexible Loop Electrosurgical ElectrodeRubicor Medical, Inc. · 2007 · 2 generations on0descendants
- K030473Senorx ES-300Senorx, Inc. · 2003 · cites it directly0descendants
- K021707Single Step Biopsy Device, Single Step Surgical Handle, Single Step Driver, Single Step…Senorx, Inc. · 2002 · 2 generations on0descendants
- K012129Ortho Development Orion-I Emf SystemOrtho Development Corp. · 2001 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K001407 | Surgitron Iec II | Ellman Intl., Inc. | 2000 | — |
| +1 | K012799 | ES-2000 Shape Select Electrosurgical Scalpel | Senorx, Inc. | 2001 | — |
| +2 | K070275 | Flexible Loop Electrosurgical Electrode | Rubicor Medical, Inc. | 2007 | — |
| +1 | K030473 | Senorx ES-300 | Senorx, Inc. | 2003 | — |
| +2 | K021707 | Single Step Biopsy Device, Single Step Surgical Handle, Single Step Driver… | Senorx, Inc. | 2002 | — |
| +1 | K012129 | Ortho Development Orion-I Emf System | Ortho Development Corp. | 2001 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2007 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (5)
3 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, K012799 (Senorx, Inc., 2001) has gone furthest, with 2 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 | — |
https://510kreport.com/device/K001407 · printed Nov 5, 2026
Cite this page
510(k) Report. “K001407: Surgitron Iec II.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K001407
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026