510(k) · Cleared
ClearedSurgi Max Ultra
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 May 3, 2017 as substantially equivalent to K100390 (Elliquence, LLC, 2010) and 1 other predicate after a 111-day review. Its family tree reaches back 5 generations to 1994. 7 later devices descend from it.
- Decided
- May 3, 2017
- Review
- 111 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K933002 (1994). 13 ancestors in all, the oldest K933157 (1994). 7 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK933002 Erbotom Icc 350Erbe USA, Inc. · 1994
- 4 generations backK023886 Erbe Vio Esu with Accessories, Model Vio 300 DErbe USA, Inc. · 2002
- 3 generations backK060484 Erbe Vio Esu, Model Vio 300 DErbe USA, Inc. · 2006
- 2 generations backK083452 Erbe Model Vio 300 D with AccessoriesErbe USA, Inc. · 2008
- 1 generation backK134054 Bovie Ids-310 High Frequency Electrosurgical Generator, Aaron A3350…Bovie Medical Corporation · 2014
- This deviceK170107 Surgi Max UltraElliquence, LLC · 2017
- 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 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · 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 | K933002 | Erbotom Icc 350 | Erbe USA, Inc. | 1994 | — |
| −4 | K023886 | Erbe Vio Esu with Accessories, Model Vio 300 D | Erbe USA, Inc. | 2002 | — |
| −3 | K060484 | Erbe Vio Esu, Model Vio 300 D | Erbe USA, Inc. | 2006 | — |
| −2 | K083452 | Erbe Model Vio 300 D with Accessories | Erbe USA, Inc. | 2008 | — |
| −1 | K134054 | Bovie Ids-310 High Frequency Electrosurgical Generator, Aaron A3350 High… | Bovie Medical Corporation | 2014 | — |
| 0 (this device) | K170107 | Surgi Max Ultra | Elliquence, LLC | 2017 | — |
| +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 |
|---|---|---|
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
| 2006 | 1 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K100390 | Surgimax/ Surgimax PlusSummary page 5…evice and Accessories; 21 CFR 878.4400 Class FDA Classification: Class II FDA Product Code: GEI Predicate Devices (807.92(a)(3)) • Surgi-Max® / Surgi-Max® Plus (K100390) • Bovie® IDS-310 Electrosurgical Generator (K134054) Device Description (807.92(a)(4)) The elliquence Surgi-Max® Ultra (… | 2010 |
| * | K134054 | Bovie Ids-310 High Frequency Electrosurgical Generator, Aaron A3350 High Frequency…Summary page 5…ation: Class II FDA Product Code: GEI Predicate Devices (807.92(a)(3)) • Surgi-Max® / Surgi-Max® Plus (K100390) • Bovie® IDS-310 Electrosurgical Generator (K134054) Device Description (807.92(a)(4)) The elliquence Surgi-Max® Ultra (IEC6-SP170, IEC6-SU170, & IEC6-SV170) is a modification to… | 2014 |
What descends from it? (7)
2 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 23 years and passes through 3 companies; a new generation was cleared every 3.3 years on median.
- None of the 13 ancestors has a recall.
- Of its descendants, K183611 (Soniquence, LLC, 2019) has gone furthest, with 5 descendants of its own.
- 1 other device also cites its predicate K100390.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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?
Orthopedic, arthroscopic, spinal, and neurological For resection, ablation, and coagulation of soft tissues and hemostasis of blood vessels in orthopedic, arthroscopic, spinal and neurological procedures. For soft tissue resection and ablation during arthroscopic surgical procedures of knee, shoulder, ankle, elbow, hip and wrist. Cutting Snoring, Submucosal palatal shrinkage, traditional uvulopalatoplasty (RAUP), myringotomy with effective hemorrhage…
Read the full statement (155 words)
Orthopedic, arthroscopic, spinal, and neurological
For resection, ablation, and coagulation of soft tissues and hemostasis of blood vessels in orthopedic, arthroscopic, spinal and neurological procedures. For soft tissue resection and ablation during arthroscopic surgical procedures of knee, shoulder, ankle, elbow, hip and wrist.
Cutting
Snoring, Submucosal palatal shrinkage, traditional uvulopalatoplasty (RAUP), myringotomy with effective hemorrhage control, epistaxis treatment, and turbinate shrinkage, skin incisions, biopsy, cysts, abscesses, tumors, cosmetic repairs, development of skin flaps, skin tags, Blepharoplasty.
Blended Cutting and Coagulation
Snoring, Submucosal palatal shrinkage, traditional uvulopalatoplasty (RAUP), myringotomy with effective hemorrhage control, epistaxis treatment, and turbinate shrinkage, skin tags, papilloma Keloids, Keratosis, Verrucae, Basal Cell Carcinoma, Nevi, Fistulas, Epithelioma, Cosmetic Repairs, Cysts, Abscesses, Development of skin flaps.
Hemostasis and Nonablative Coagulation
Control of bleeding, Epilation, Telangiectasia
Bipolar
Pinpoint, Precise Coagulation, Pinpoint Hemostasis, in any field (wet or dry), snoring, sub-mucosal palatal shrinkage, traditional uvulopalatoplasty (RAUP), myringotomy with effective hemorrhage control, epistaxis treatment, and turbinate shrinkage.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K170107 · printed Nov 4, 2026
Cite this page
510(k) Report. “K170107: Surgi Max Ultra.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K170107
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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