510(k) · Cleared
ClearedCobra Cooled Surgical Probe, Model M004159670
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific Corp · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Aug 20, 2003 as substantially equivalent to K023291 (Boston Scientific Corp, 2002) after a 33-day review. Its family tree reaches back 2 generations to 1998. 1 later device descends from it.
- Decided
- Aug 20, 2003
- Review
- 33 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K981981 (1998). 3 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK981981 Electrosurgical Unit (Esu) (115 Volt) Model 4810, Electrosurgical…Boston Scientific Corp · 1998
- 1 generation backK023291 Cobra Cooled Cardiac Surgical Probe, Model 1596XBoston Scientific Corp · 2002
- This deviceK032207 Cobra Cooled Surgical Probe, Model M004159670Boston Scientific Corp · 2003
- Descendant · cites it directly · 0 of its ownK040104 Cobra Adhere Surgical System, Model M00415977C0Boston Scientific Corp · 2004
Most influential descendants
Showing 1 of 1 · See all- K040104Cobra Adhere Surgical System, Model M00415977C0Boston Scientific Corp · 2004 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K981981 | Electrosurgical Unit (Esu) (115 Volt) Model 4810, Electrosurgical Unit (Esu)… | Boston Scientific Corp | 1998 | — |
| −1 | K023291 | Cobra Cooled Cardiac Surgical Probe, Model 1596X | Boston Scientific Corp | 2002 | — |
| 0 (this device) | K032207 | Cobra Cooled Surgical Probe, Model M004159670 | Boston Scientific Corp | 2003 | — |
| +1 | K040104 | Cobra Adhere Surgical System, Model M00415977C0 | Boston Scientific Corp | 2004 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 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 |
|---|---|---|---|
| * | K023291 | Cobra Cooled Cardiac Surgical Probe, Model 1596XSummary page 1…evice Classification: 21 CFR 9878.4400 Predicate Device Information Predicate Device: Cobra Cooled Surgical Probe (K023291) Predicate Device Manufacturer: Boston Scientific Corporation Predicate Device Common Name El… | 2002 |
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 |
|---|---|---|---|
| K040104 | Cobra Adhere Surgical System, Model M00415977C0 | 2004 | 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?
- The line of descent spans 5 years and passes through 1 company; a new generation was cleared every 4.1 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K040104 (Boston Scientific Corp, 2004) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K023291.
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 intended use for Cobra Cooled Surgical Probe is as follows:
The Cobra Cooled Surgical Probe is intended for the coagulation of cardiac tissue using radiofrequency (RF) energy during cardiac surgery. The Probe can be used during general surgery to coagulate soft tissues. The Probe may also be used to coagulate blood and soft tissue to produce hemostasis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K032207 · printed Nov 6, 2026
Cite this page
510(k) Report. “K032207: Cobra Cooled Surgical Probe, Model M004159670.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K032207
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