510(k) · Cleared
ClearedOratec Model Endotac Probe
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Oratec Interventions, Inc. · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Jan 23, 1998 after a 212-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 21 later devices descend from it.
- Decided
- Jan 23, 1998
- Review
- 212 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 0
21 later devices descend from it, 1 citing it directly.
- This deviceK972358 Oratec Model Endotac ProbeOratec Interventions, Inc. · 1998
- Descendant · cites it directly · 20 of its ownK974464 Oratec Spinecath Intradiscal CatheterOratec Interventions, Inc. · 1998
- Descendant · 2 generations on · 16 of its ownK993854 Ora-50 S Autotemp Electrothermal Spine System and AccessoriesOratec Interventions, Inc. · 1999
- Descendant · 3 generations on · 14 of its ownK033981 Smith & Nephew Electrothermal 20S Spine Generator, Model 7209975Smith & Nephew, Inc. · 2004
- Descendant · 4 generations on · 11 of its ownK130689 Symphony RF GeneratorThermigen, Inc. · 2013
- Descendant · 5 generations on · 6 of its ownK171094 Thermi Reusable Non-invasive RF ElectrodeThermgen, L.L.C · 2017
Showing 5 of 21 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 21 · See all- K974464Oratec Spinecath Intradiscal CatheterOratec Interventions, Inc. · 1998 · cites it directly20descendants
- K993854Ora-50 S Autotemp Electrothermal Spine System and AccessoriesOratec Interventions, Inc. · 1999 · 2 generations on16descendants
- K033981Smith & Nephew Electrothermal 20S Spine Generator, Model 7209975Smith & Nephew, Inc. · 2004 · 3 generations on14descendants
- K130689Symphony RF GeneratorThermigen, Inc. · 2013 · 4 generations on11descendants
- K171094Thermi Reusable Non-invasive RF ElectrodeThermgen, L.L.C · 2017 · 5 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K972358 | Oratec Model Endotac Probe | Oratec Interventions, Inc. | 1998 | — |
| +1 | K974464 | Oratec Spinecath Intradiscal Catheter | Oratec Interventions, Inc. | 1998 | — |
| +2 | K993854 | Ora-50 S Autotemp Electrothermal Spine System and Accessories | Oratec Interventions, Inc. | 1999 | — |
| +3 | K033981 | Smith & Nephew Electrothermal 20S Spine Generator, Model 7209975 | Smith & Nephew, Inc. | 2004 | — |
| +4 | K130689 | Symphony RF Generator | Thermigen, Inc. | 2013 | — |
| +5 | K171094 | Thermi Reusable Non-invasive RF Electrode | Thermgen, L.L.C | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2013 | 1 | 0 |
| 2016 | 3 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2023 | 2 | 0 |
| 2025 | 1 | 0 |
| 2026 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (21)
See all 211 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K974464 | Oratec Spinecath Intradiscal Catheter | 1998 | 20 |
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, K974464 (Oratec Interventions, Inc., 1998) has gone furthest, with 20 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?
Model EndoTAC™ Monopolar Cautery Probe is designed for hemostasis, and for coagulation and desiccation of disc material to treat disc annulus disruption and degenerative disc diseases of contained herniated disc.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K972358 · printed Nov 6, 2026
Cite this page
510(k) Report. “K972358: Oratec Model Endotac Probe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K972358
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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