510(k) · Cleared
ClearedBergen 610 Bipolar Coagulator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bergen Mfg. · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Feb 27, 1997 after a 94-day review. The FDA summary names no predicate by number. 979 later devices descend from it.
- Decided
- Feb 27, 1997
- Review
- 94 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 0
979 later devices descend from it, 2 citing it directly.
- This deviceK964736 Bergen 610 Bipolar CoagulatorBergen Mfg. · 1997
- Descendant · cites it directly · 978 of its ownK972299 Bergen Model 500 Electrosurgery GeneratorBergen Mfg. · 1997
- Descendant · cites it directly · 977 of its ownK974521 Vnus Closure SystemVnus Medical Technologies, Inc. · 1998
- Descendant · 2 generations on · 973 of its ownK982816 Vnus Closure SystemVnus Medical Technologies, Inc. · 1999
- Descendant · 2 generations on · 714 of its ownK012398 Diomed 15 Diode LaserDiomed, Ltd. · 2002
- Descendant · 3 generations on · 705 of its ownK022266 Aurora SRSyneron Medical, Ltd. · 2002
Showing 5 of 979 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 979 · See all- K972299Bergen Model 500 Electrosurgery GeneratorBergen Mfg. · 1997 · cites it directly978descendants
- K974521Vnus Closure SystemVnus Medical Technologies, Inc. · 1998 · cites it directly977descendants
- K982816Vnus Closure SystemVnus Medical Technologies, Inc. · 1999 · 2 generations on973descendants
- K012398Diomed 15 Diode LaserDiomed, Ltd. · 2002 · 2 generations on714descendants
- K022266Aurora SRSyneron Medical, Ltd. · 2002 · 3 generations on705descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K964736 | Bergen 610 Bipolar Coagulator | Bergen Mfg. | 1997 | — |
| +1 | K972299 | Bergen Model 500 Electrosurgery Generator | Bergen Mfg. | 1997 | — |
| +1 | K974521 | Vnus Closure System | Vnus Medical Technologies, Inc. | 1998 | — |
| +2 | K982816 | Vnus Closure System | Vnus Medical Technologies, Inc. | 1999 | — |
| +2 | K012398 | Diomed 15 Diode Laser | Diomed, Ltd. | 2002 | — |
| +3 | K022266 | Aurora SR | Syneron Medical, Ltd. | 2002 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2002 | 4 | 0 |
| 2003 | 9 | 0 |
| 2004 | 6 | 0 |
| 2005 | 12 | 0 |
| 2006 | 8 | 0 |
| 2007 | 12 | 0 |
| 2008 | 26 | 0 |
| 2009 | 20 | 0 |
| 2010 | 27 | 0 |
| 2011 | 20 | 0 |
| 2012 | 19 | 0 |
| 2013 | 26 | 0 |
| 2014 | 37 | 0 |
| 2015 | 36 | 0 |
| 2016 | 50 | 0 |
| 2017 | 52 | 0 |
| 2018 | 48 | 0 |
| 2019 | 35 | 0 |
| 2020 | 47 | 0 |
| 2021 | 47 | 0 |
| 2022 | 70 | 0 |
| 2023 | 66 | 0 |
| 2024 | 92 | 0 |
| 2025 | 131 | 0 |
| 2026 | 76 | 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?
The FDA summary names no predicate by number.
What descends from it? (979)
See all 9792 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, K972299 (Bergen Mfg., 1997) has gone furthest, with 978 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/K964736 · printed Nov 5, 2026
Cite this page
510(k) Report. “K964736: Bergen 610 Bipolar Coagulator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K964736
Report an extraction error
Are you the manufacturer?
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