510(k) · Cleared
ClearedElectrosurgical Pencil with Ptfe Coated & Uncoated Electrode Tips
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Xodus Medical, Inc. · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Aug 12, 2008 as substantially equivalent to K965054 (Megadyne Medical Products, Inc., 1997) after a 61-day review. Its family tree reaches back 1 generation to 1997. 1 later device descends from it.
- Decided
- Aug 12, 2008
- Review
- 61 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K965054 (1997). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK965054 PencilMegadyne Medical Products, Inc. · 1997 · Recalled
- This deviceK081647 Electrosurgical Pencil with Ptfe Coated & Uncoated Electrode TipsXodus Medical, Inc. · 2008
- Descendant · cites it directly · 0 of its ownK230621 LaproGlide™ Disposable Monopolar PTFE Coated Laparoscopic ProbesSurgical Principals, Inc. · 2023
Most influential descendants
Showing 1 of 1 · See all- K230621LaproGlide™ Disposable Monopolar PTFE Coated Laparoscopic ProbesSurgical Principals, Inc. · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K965054 | Pencil | Megadyne Medical Products, Inc. | 1997 | 8 |
| 0 (this device) | K081647 | Electrosurgical Pencil with Ptfe Coated & Uncoated Electrode Tips | Xodus Medical, Inc. | 2008 | — |
| +1 | K230621 | LaproGlide™ Disposable Monopolar PTFE Coated Laparoscopic Probes | Surgical Principals, Inc. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 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? (1)
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 |
|---|---|---|---|
| * | K965054 | PencilSummary page 1…Code: GEI Regulatory Class: II Predicate Device Device Name: Electrosurgical Pencil with PTFE Coated & Uncoated Electrode Tips Common Name: ES Pencil 510 (k) Number: K965054 510 (k) Owner: MegaDyne Medical Products, Inc. Classification Name: Electrosurgical, Cutting & Coagulation Device & Accessories… | 1997 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K230621 | LaproGlide™ Disposable Monopolar PTFE Coated Laparoscopic Probes | 2023 | 0 |
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?
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
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 intended use for this device is to conduct monopolar electrosurgical energy from an electrosurgical unit (ESU), to an electrosurgical electrode consequently to the intended tissue to be cut and/or coagulated.
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/K081647 · printed Nov 4, 2026
Cite this page
510(k) Report. “K081647: Electrosurgical Pencil with Ptfe Coated & Uncoated Electrode Tips.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K081647
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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