510(k) · Cleared
Recalled · 2009Pulsar Generator, Peak Plasmablade; 4.0, Needle, and Ext Tissue Dissection Devices
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Peak Surgical, Inc. · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Dec 3, 2008 as substantially equivalent to K073057 (Peak Surgical, Inc., 2008) and 2 other predicates after a 71-day review. Its family tree reaches back 3 generations to 1994. 24 later devices descend from it. It has been recalled once.
- Decided
- Dec 3, 2008
- Review
- 71 days
- Class
- Class II
- Product code
- GEI
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 3 generations to K933157 (1994). 19 ancestors in all, the oldest K780977 (1978). 24 later devices descend from it, 7 citing it directly.
- Root · 3 generations backK933157 Erbotom Icc 200Erbe USA, Inc. · 1994
- 2 generations backK013255 Surgitron 120 Iec (Also Known as Surgitron 4.0 Dual RFEllman Intl., Inc. · 2001
- 1 generation backK061174 Surgi-MaxEllman Int'L, Inc. · 2006
- This deviceK082786 Pulsar Generator, Peak Plasmablade; 4.0, Needle, and Ext Tissue…Peak Surgical, Inc. · 2008
- Descendant · cites it directly · 8 of its ownK093695 Peak Plasmablade 3.OS Tissue Dissection DevicePeak Surgical, Inc. · 2010
- Descendant · cites it directly · 7 of its ownK142410 Elliquence ElectrodesElliquence, LLC · 2015
- Descendant · cites it directly · 6 of its ownK160041 Cobbra RF Tissue DissectorElliquence, LLC · 2016
- Descendant · 2 generations on · 5 of its ownK183611 Soniquence RF Generator and Soniquence ElectrodesSoniquence, LLC · 2019
- Descendant · cites it directly · 4 of its ownK121881 Domain Surgical SystemDomain Surgical, Inc. · 2012
Showing 5 of 24 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 24 · See all- K093695Peak Plasmablade 3.OS Tissue Dissection DevicePeak Surgical, Inc. · 2010 · cites it directly8descendants
- K142410Elliquence ElectrodesElliquence, LLC · 2015 · cites it directly7descendants
- K160041Cobbra RF Tissue DissectorElliquence, LLC · 2016 · cites it directly6descendants
- K183611Soniquence RF Generator and Soniquence ElectrodesSoniquence, LLC · 2019 · 2 generations on5descendants
- K121881Domain Surgical SystemDomain Surgical, Inc. · 2012 · cites it directly4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K933157 | Erbotom Icc 200 | Erbe USA, Inc. | 1994 | — |
| −2 | K013255 | Surgitron 120 Iec (Also Known as Surgitron 4.0 Dual RF | Ellman Intl., Inc. | 2001 | — |
| −1 | K061174 | Surgi-Max | Ellman Int'L, Inc. | 2006 | — |
| 0 (this device) | K082786 | Pulsar Generator, Peak Plasmablade; 4.0, Needle, and Ext Tissue Dissection… | Peak Surgical, Inc. | 2008 | — |
| +1 | K093695 | Peak Plasmablade 3.OS Tissue Dissection Device | Peak Surgical, Inc. | 2010 | — |
| +1 | K142410 | Elliquence Electrodes | Elliquence, LLC | 2015 | — |
| +1 | K160041 | Cobbra RF Tissue Dissector | Elliquence, LLC | 2016 | — |
| +2 | K183611 | Soniquence RF Generator and Soniquence Electrodes | Soniquence, LLC | 2019 | — |
| +1 | K121881 | Domain Surgical System | Domain Surgical, Inc. | 2012 | — |
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 |
| 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 |
|---|---|---|
| 2010 | 3 | 0 |
| 2012 | 1 | 0 |
| 2014 | 4 | 0 |
| 2015 | 2 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 3 | 0 |
| 2022 | 3 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 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? (3)
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 |
|---|---|---|---|
| * | K073057 | Pulsar Generator, Model PS100-100, and Peak Plasmablade Tissue Dissection Device, Model…Summary page 1…Accessories (21 CFR 878.4400) 3. Predicate Devices: PULSAR Generator and PEAK PlasmaBlade Tissue Dissection Device (K073057) Ellman Surgi-Max Generator (K061174) ELECTROMEDICS FAS-CLEAN electrode (K073616) 4.… | 2008 |
| * | K061174 | Surgi-MaxSummary page 1…Predicate Devices: PULSAR Generator and PEAK PlasmaBlade Tissue Dissection Device (K073057) Ellman Surgi-Max Generator (K061174) ELECTROMEDICS FAS-CLEAN electrode (K073616) 4. Device description: The PEAK Surge… | 2006 |
| * | K073616 | Fas-Clean Electrosurgical Coated Active BladeSummary page 1…AK PlasmaBlade Tissue Dissection Device (K073057) Ellman Surgi-Max Generator (K061174) ELECTROMEDICS FAS-CLEAN electrode (K073616) 4. Device description: The PEAK Surgery System consists of the PULSAR Generator, PEAK… | 2008 |
What descends from it? (24)
See all 247 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K093695 | Peak Plasmablade 3.OS Tissue Dissection Device | 2010 | 8 |
| K142410 | Elliquence Electrodes | 2015 | 7 |
| K160041 | Cobbra RF Tissue Dissector | 2016 | 6 |
| K121881 | Domain Surgical System | 2012 | 4 |
| K181257 | PlasmaBlade X 3.0S, PlasmaBlade X 4.0 | 2018 | 3 |
| K143175 | AEx Generator; PlasmaBlade T | 2014 | 1 |
| K102029 | Peak Pulsar II Generator Model PS100-102 | 2010 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 19, 2009 | Not classified | Z-1022-2011 | Other | A customer reported that a patient suffered a burn while using the device. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 14 years and passes through 4 companies; a new generation was cleared every 4.6 years on median.
- 4 of the 19 ancestors have a recall of any class.
- Of its descendants, K093695 (Peak Surgical, Inc., 2010) has gone furthest, with 8 descendants of its own.
- 2 other devices also cite its predicate K073057.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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 PEAK Surgery System is indicated for cutting and coagulation of soft tissue during General, Plastic and Reconstructive (including but not limited to skin incisions and development of skin flaps), ENT, Gynecologic, Orthopaedic, Arthroscopic, Spinal and Neurological surgical procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082786 · printed Nov 5, 2026
Cite this page
510(k) Report. “K082786: Pulsar Generator, Peak Plasmablade; 4.0, Needle, and Ext Tissue Dissection Devices.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K082786
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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