510(k) · Cleared
ClearedCobra Adhere Surgical System, Model M00415977C0
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 Feb 18, 2004 as substantially equivalent to K032207 (Boston Scientific Corp, 2003) after a 29-day review. Its family tree reaches back 3 generations to 1998.
- Decided
- Feb 18, 2004
- Review
- 29 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K981981 (1998). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK981981 Electrosurgical Unit (Esu) (115 Volt) Model 4810, Electrosurgical…Boston Scientific Corp · 1998
- 2 generations backK023291 Cobra Cooled Cardiac Surgical Probe, Model 1596XBoston Scientific Corp · 2002
- 1 generation backK032207 Cobra Cooled Surgical Probe, Model M004159670Boston Scientific Corp · 2003
- This deviceK040104 Cobra Adhere Surgical System, Model M00415977C0Boston Scientific Corp · 2004
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K981981 | Electrosurgical Unit (Esu) (115 Volt) Model 4810, Electrosurgical Unit (Esu)… | Boston Scientific Corp | 1998 | — |
| −2 | K023291 | Cobra Cooled Cardiac Surgical Probe, Model 1596X | Boston Scientific Corp | 2002 | — |
| −1 | K032207 | Cobra Cooled Surgical Probe, Model M004159670 | Boston Scientific Corp | 2003 | — |
| 0 (this device) | 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 |
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 |
|---|---|---|---|
| * | K032207 | Cobra Cooled Surgical Probe, Model M004159670Summary page 1…ce Classification: I21 CFR §878.4400 Predicate Device Information Predicate Device: Cobra Cooled Surgical Probe (K032207) Predicate Device Manufacturer: Boston Scientific Corporation Predicate Device Common Name I[… | 2003 |
What descends from it?
No later submission names this one as a predicate yet.
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 6 years and passes through 1 company; a new generation was cleared every 10 months on median.
- None of the 4 ancestors has a recall.
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 Adhere Surgical System is as follows:
The Cobra Adhere Surgical System (System) is intended for the coagulation of cardiac tissue using radiofrequency (RF) energy during cardiac surgery. The System can be used during general surgery to coagulate soft tissues. The System 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/K040104 · printed Nov 4, 2026
Cite this page
510(k) Report. “K040104: Cobra Adhere Surgical System, Model M00415977C0.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K040104
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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