510(k) · Cleared
ClearedBipolar Pencil Coagulator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kirwan Surgical Products, Inc. · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Aug 14, 1996 after a 35-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 4 later devices descend from it.
- Decided
- Aug 14, 1996
- Review
- 35 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 2 citing it directly.
- This deviceK962678 Bipolar Pencil CoagulatorKirwan Surgical Products, Inc. · 1996
- Descendant · cites it directly · 2 of its ownK024304 Microsurgical Bipolar HandpieceNeomedix Corp. · 2003
- Descendant · 2 generations on · 1 of its ownK040584 NMX-1000Neomedix Corp. · 2004
- Descendant · 3 generations on · 0 of its ownK220891 Kahook Dual Blade Glide (KDB Glide)New World Medical, Inc. · 2024
- Descendant · cites it directly · 0 of its ownK072911 Ion Medical Bipolar Coagulation PenIon Medical, LLC · 2007
Most influential descendants
Showing 4 of 4 · See all- K024304Microsurgical Bipolar HandpieceNeomedix Corp. · 2003 · cites it directly2descendants
- K040584NMX-1000Neomedix Corp. · 2004 · 2 generations on1descendant
- K220891Kahook Dual Blade Glide (KDB Glide)New World Medical, Inc. · 2024 · 3 generations on0descendants
- K072911Ion Medical Bipolar Coagulation PenIon Medical, LLC · 2007 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K962678 | Bipolar Pencil Coagulator | Kirwan Surgical Products, Inc. | 1996 | — |
| +1 | K024304 | Microsurgical Bipolar Handpiece | Neomedix Corp. | 2003 | — |
| +2 | K040584 | NMX-1000 | Neomedix Corp. | 2004 | — |
| +3 | K220891 | Kahook Dual Blade Glide (KDB Glide) | New World Medical, Inc. | 2024 | — |
| +1 | K072911 | Ion Medical Bipolar Coagulation Pen | Ion Medical, LLC | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2007 | 1 | 0 |
| 2024 | 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? (4)
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, K024304 (Neomedix Corp., 2003) 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/K962678 · printed Nov 5, 2026
Cite this page
510(k) Report. “K962678: Bipolar Pencil Coagulator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K962678
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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