510(k) · Cleared
ClearedCobra Bipolar Clamp, Model 15902
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific EP Technologies · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Apr 2, 2003 as substantially equivalent to K013873 (Boston Scientific Corp, 2002) after a 182-day review. Its family tree reaches back 3 generations to 1992. 46 later devices descend from it.
- Decided
- Apr 2, 2003
- Review
- 182 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K921884 (1992). 8 ancestors in all, the oldest K870705 (1987). 46 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK921884 FORCE 2Valleylab, Inc. · 1992
- 2 generations backK013392 Cardioblate Surgical Ablation Pen, Model 60811C; Cardioblate…Medtronic Vascular · 2002 · Recalled
- 1 generation backK013873 Cobra Cardiac Electrosurgical SystemBoston Scientific Corp · 2002
- This deviceK023288 Cobra Bipolar Clamp, Model 15902Boston Scientific EP Technologies · 2003
- Descendant · cites it directly · 42 of its ownK040690 Surgifrost 10 CM Cryosurgical Device Plus Frostbyte Clamp and…Cryocath Technologies, Inc. · 2004
- Descendant · cites it directly · 22 of its ownK053436 Surgifrost 6CM, 7CM and 10 CM Cryosurgical Devices Plus Frostbyte…Cryocath Technologies, Inc. · 2006 · Recalled
- Descendant · 2 generations on · 18 of its ownK043579 Atricure Bipolar SystemAtriCure, Inc. · 2007
- Descendant · 2 generations on · 16 of its ownK082074 Atricure CRYO1 Cryo-Ablation ProbeAtriCure, Inc. · 2009 · Recalled
- Descendant · 3 generations on · 14 of its ownK111042 Atricure Cryo ModuleAtriCure, Inc. · 2011
Showing 5 of 46 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 46 · See all- K040690Surgifrost 10 CM Cryosurgical Device Plus Frostbyte Clamp and Cryosurgical ConsoleCryocath Technologies, Inc. · 2004 · cites it directly42descendants
- K053436Surgifrost 6CM, 7CM and 10 CM Cryosurgical Devices Plus Frostbyte Clamp and Cryosurgical…Cryocath Technologies, Inc. · 2006 · cites it directly22descendants
- K043579Atricure Bipolar SystemAtriCure, Inc. · 2007 · 2 generations on18descendants
- K082074Atricure CRYO1 Cryo-Ablation ProbeAtriCure, Inc. · 2009 · 2 generations on16descendants
- K111042Atricure Cryo ModuleAtriCure, Inc. · 2011 · 3 generations on14descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K921884 | FORCE 2 | Valleylab, Inc. | 1992 | — |
| −2 | K013392 | Cardioblate Surgical Ablation Pen, Model 60811C; Cardioblate Surgical Ablation… | Medtronic Vascular | 2002 | 1 |
| −1 | K013873 | Cobra Cardiac Electrosurgical System | Boston Scientific Corp | 2002 | — |
| 0 (this device) | K023288 | Cobra Bipolar Clamp, Model 15902 | Boston Scientific EP Technologies | 2003 | — |
| +1 | K040690 | Surgifrost 10 CM Cryosurgical Device Plus Frostbyte Clamp and Cryosurgical… | Cryocath Technologies, Inc. | 2004 | — |
| +1 | K053436 | Surgifrost 6CM, 7CM and 10 CM Cryosurgical Devices Plus Frostbyte Clamp and… | Cryocath Technologies, Inc. | 2006 | 1 |
| +2 | K043579 | Atricure Bipolar System | AtriCure, Inc. | 2007 | — |
| +2 | K082074 | Atricure CRYO1 Cryo-Ablation Probe | AtriCure, Inc. | 2009 | 1 |
| +3 | K111042 | Atricure Cryo Module | AtriCure, Inc. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 2001 | 4 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 2 | 0 |
| 2010 | 3 | 0 |
| 2011 | 3 | 0 |
| 2012 | 4 | 0 |
| 2013 | 2 | 0 |
| 2014 | 4 | 0 |
| 2016 | 1 | 0 |
| 2018 | 4 | 0 |
| 2019 | 3 | 0 |
| 2020 | 2 | 0 |
| 2021 | 2 | 0 |
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 3 | 0 |
| 2025 | 2 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K013873 | Cobra Cardiac Electrosurgical System Our OCR of the scanned summary read K013783, FDA’s number for Aution Max AX-4280 Urinalysis System (International Remote Imaging Systems). Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “Cobra Electrosurgical Probe”. | 2002 |
What descends from it? (46)
See all 463 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?
- The line of descent spans 11 years and passes through 4 companies; a new generation was cleared every 9 months on median.
- 1 of the 8 ancestors has a recall of any class.
- Of its descendants, K040690 (Cryocath Technologies, Inc., 2004) has gone furthest, with 42 descendants of its own.
- 5 other devices also cite its predicate K013873.
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?
The Cobra Bipolar System (System) is intended for the coagulation of soft tissue during general surgery. The System may also be used to coagulate blood and soft tissue to produce hemostasis,
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/K023288 · printed Nov 6, 2026
Cite this page
510(k) Report. “K023288: Cobra Bipolar Clamp, Model 15902.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023288
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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