510(k) · Cleared
ClearedTeflon Coated Electrodes/Electrodes Handles
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Olsen Electrosurgical, Inc. · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Dec 23, 1991 after a 164-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 3 later devices descend from it.
- Decided
- Dec 23, 1991
- Review
- 164 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 2 citing it directly.
- This deviceK913108 Teflon Coated Electrodes/Electrodes HandlesOlsen Electrosurgical, Inc. · 1991
- Descendant · cites it directly · 1 of its ownK981188 Electrosurgical Cautery ProbesMicroline Pentax, Inc. · 1998
- Descendant · 2 generations on · 0 of its ownK151480 Epix Electrosurgical Probe with Smoke EvacuationApplied Medical Resources · 2016
- Descendant · cites it directly · 0 of its ownK052702 Misonix Inc. FS-1000-RF Bipolar Forceps AccessoryMisonix, Inc. · 2005
Most influential descendants
Showing 3 of 3 · See all- K981188Electrosurgical Cautery ProbesMicroline Pentax, Inc. · 1998 · cites it directly1descendant
- K151480Epix Electrosurgical Probe with Smoke EvacuationApplied Medical Resources · 2016 · 2 generations on0descendants
- K052702Misonix Inc. FS-1000-RF Bipolar Forceps AccessoryMisonix, Inc. · 2005 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K913108 | Teflon Coated Electrodes/Electrodes Handles | Olsen Electrosurgical, Inc. | 1991 | — |
| +1 | K981188 | Electrosurgical Cautery Probes | Microline Pentax, Inc. | 1998 | — |
| +2 | K151480 | Epix Electrosurgical Probe with Smoke Evacuation | Applied Medical Resources | 2016 | — |
| +1 | K052702 | Misonix Inc. FS-1000-RF Bipolar Forceps Accessory | Misonix, Inc. | 2005 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2005 | 1 | 0 |
| 2016 | 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (3)
2 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, K981188 (Microline Pentax, Inc., 1998) 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.
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/K913108 · printed Nov 6, 2026
Cite this page
510(k) Report. “K913108: Teflon Coated Electrodes/Electrodes Handles.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K913108
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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