510(k) · Cleared
ClearedCobbra RF Tissue Dissector
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Elliquence, LLC · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Mar 7, 2016 as substantially equivalent to K142410 (Elliquence, LLC, 2015) and 1 other predicate after a 59-day review. Its family tree reaches back 5 generations to 1994. 6 later devices descend from it.
- Decided
- Mar 7, 2016
- Review
- 59 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K933157 (1994). 22 ancestors in all, the oldest K780977 (1978). 6 later devices descend from it, 1 citing it directly.
- Root · 5 generations backK933157 Erbotom Icc 200Erbe USA, Inc. · 1994
- 4 generations backK013255 Surgitron 120 Iec (Also Known as Surgitron 4.0 Dual RFEllman Intl., Inc. · 2001
- 3 generations backK061174 Surgi-MaxEllman Int'L, Inc. · 2006
- 2 generations backK082786 Pulsar Generator, Peak Plasmablade; 4.0, Needle, and Ext Tissue…Peak Surgical, Inc. · 2008 · Recalled
- 1 generation backK142410 Elliquence ElectrodesElliquence, LLC · 2015
- This deviceK160041 Cobbra RF Tissue DissectorElliquence, LLC · 2016
- Descendant · cites it directly · 5 of its ownK183611 Soniquence RF Generator and Soniquence ElectrodesSoniquence, LLC · 2019
- Descendant · 2 generations on · 1 of its ownK212222 Soniquence Reusable 3 Button Fingerswitch WandSoniquence, LLC · 2022
- Descendant · 2 generations on · 1 of its ownK202562 Ellusa Generator, Ellusa Bayonet Tip, Ellusa RF-Cobb Tip, Ellusa…Ellusa, LLC · 2020
- Descendant · 2 generations on · 0 of its ownK254220 Reusable 3 Button Fingerswitch WandSoniquence, LLC · 2026
- Descendant · 3 generations on · 0 of its ownK222425 Ellusa Reusable Neutral PlatesEllusa, LLC · 2022
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K183611Soniquence RF Generator and Soniquence ElectrodesSoniquence, LLC · 2019 · cites it directly5descendants
- K212222Soniquence Reusable 3 Button Fingerswitch WandSoniquence, LLC · 2022 · 2 generations on1descendant
- K202562Ellusa Generator, Ellusa Bayonet Tip, Ellusa RF-Cobb Tip, Ellusa SP-Pack and Tips…Ellusa, LLC · 2020 · 2 generations on1descendant
- K254220Reusable 3 Button Fingerswitch WandSoniquence, LLC · 2026 · 2 generations on0descendants
- K222425Ellusa Reusable Neutral PlatesEllusa, LLC · 2022 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K933157 | Erbotom Icc 200 | Erbe USA, Inc. | 1994 | — |
| −4 | K013255 | Surgitron 120 Iec (Also Known as Surgitron 4.0 Dual RF | Ellman Intl., Inc. | 2001 | — |
| −3 | K061174 | Surgi-Max | Ellman Int'L, Inc. | 2006 | — |
| −2 | K082786 | Pulsar Generator, Peak Plasmablade; 4.0, Needle, and Ext Tissue Dissection… | Peak Surgical, Inc. | 2008 | 1 |
| −1 | K142410 | Elliquence Electrodes | Elliquence, LLC | 2015 | — |
| 0 (this device) | K160041 | Cobbra RF Tissue Dissector | Elliquence, LLC | 2016 | — |
| +1 | K183611 | Soniquence RF Generator and Soniquence Electrodes | Soniquence, LLC | 2019 | — |
| +2 | K212222 | Soniquence Reusable 3 Button Fingerswitch Wand | Soniquence, LLC | 2022 | — |
| +2 | K202562 | Ellusa Generator, Ellusa Bayonet Tip, Ellusa RF-Cobb Tip, Ellusa SP-Pack and… | Ellusa, LLC | 2020 | — |
| +2 | K254220 | Reusable 3 Button Fingerswitch Wand | Soniquence, LLC | 2026 | — |
| +3 | K222425 | Ellusa Reusable Neutral Plates | Ellusa, LLC | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1979 | 1 | 0 |
| 1991 | 2 | 0 |
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 3 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2008 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 3 | 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? (2)
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 |
|---|---|---|---|
| * | K142410 | Elliquence ElectrodesSummary page 5…n Device and Accessories; 21 CFR 878.4400. Class FDA Classification: Class II FDA Product Code: GEI Predicate Devices (807.92(a)(3)) • Elliquence Electrodes (510(k) K142410) • PEAK Surgery System (510(k) K082786) Device Description (807.92(a)(4)) The CobbraTM RF Tissue Dissector is a single-use, s… | 2015 |
| * | K082786 | Pulsar Generator, Peak Plasmablade; 4.0, Needle, and Ext Tissue Dissection DevicesSummary page 5…. Class FDA Classification: Class II FDA Product Code: GEI Predicate Devices (807.92(a)(3)) • Elliquence Electrodes (510(k) K142410) • PEAK Surgery System (510(k) K082786) Device Description (807.92(a)(4)) The CobbraTM RF Tissue Dissector is a single-use, sterile, monopolar electrosurgical instrum… | 2008 |
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K183611 | Soniquence RF Generator and Soniquence Electrodes | 2019 | 5 |
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 22 years and passes through 5 companies; a new generation was cleared every 4.6 years on median.
- 5 of the 22 ancestors have a recall of any class.
- Of its descendants, K183611 (Soniquence, LLC, 2019) has gone furthest, with 5 descendants of its own.
- 1 other device also cites its predicate K142410.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
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 Cobbra RF Tissue Dissector is intended for use by a physician familiar with resection, dissection, incision, and hemostasis in soft tissue surgical procedures. The types of surgery intended are: General surgery, Laparoscopic procedures, Endoscopic procedures, Open abdominal, Orthopedic coagulation, Thorascopic coagulation, Neurosurgical coagulation Gynecological coagulation, (except for use in female sterilization), Ear, Nose, Throat coagulation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K160041 · printed Nov 6, 2026
Cite this page
510(k) Report. “K160041: Cobbra RF Tissue Dissector.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K160041
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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