510(k) Report

510(k) · Cleared

Cleared

Surgimax/ Surgimax Plus

K100390510(k) TraditionalCleared Aug 25, 2010190-day reviewClass II21 CFR 878.4400

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Elliquence, LLC · GEI Electrosurgical, Cutting & Coagulation & Accessories

Cleared on Aug 25, 2010 as substantially equivalent to K061174 (Ellman Int'L, Inc., 2006) after a 190-day review. Its family tree reaches back 3 generations to 1994. 10 later devices descend from it.

Decided
Aug 25, 2010
Review
190 days
Class
Class II
Product code
GEI
Recalls
None
Predicates
1

Its longest line of descent runs back 3 generations to K933157 (1994). 4 ancestors in all. 10 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2000: 1 other ancestor2017: 2 descendants cleared2018: 1 descendant cleared2019: 1 descendant cleared2026: 2 descendants cleared2020: 1 descendant cleared2022: 3 descendants clearedK933157 · Erbotom Icc 200 · Erbe USA, Inc. · 1994K013255 · Surgitron 120 Iec (Also Known as Surgitron 4.0 Dual RF · Ellman Intl., Inc. · 2001K061174 · Surgi-Max · Ellman Int'L, Inc. · 20061990200020102020
Other ancestors, by generationDescendants, by generation 3 generations back: 1 other ancestor 1 generation forward: 2 descendants2 generations forward: 3 descendants3 generations forward: 4 descendants4 generations forward: 1 descendant K061174 · Surgi-Max · Ellman Int'L, Inc. · 2006K013255 · Surgitron 120 Iec (Also Known as Surgitron 4.0 Dual RF · Ellman Intl., Inc. · 2001K933157 · Erbotom Icc 200 · Erbe USA, Inc. · 19940
  1. Root · 3 generations backK933157 Erbotom Icc 200Erbe USA, Inc. · 1994
  2. 2 generations backK013255 Surgitron 120 Iec (Also Known as Surgitron 4.0 Dual RFEllman Intl., Inc. · 2001
  3. 1 generation backK061174 Surgi-MaxEllman Int'L, Inc. · 2006
  4. This deviceK100390 Surgimax/ Surgimax PlusElliquence, LLC · 2010
  5. Descendant · cites it directly · 7 of its ownK170107 Surgi Max UltraElliquence, LLC · 2017
  6. Descendant · 2 generations on · 5 of its ownK183611 Soniquence RF Generator and Soniquence ElectrodesSoniquence, LLC · 2019
  7. Descendant · 3 generations on · 1 of its ownK212222 Soniquence Reusable 3 Button Fingerswitch WandSoniquence, LLC · 2022
  8. Descendant · 3 generations on · 1 of its ownK202562 Ellusa Generator, Ellusa Bayonet Tip, Ellusa RF-Cobb Tip, Ellusa…Ellusa, LLC · 2020
  9. Descendant · cites it directly · 1 of its ownK171869 Sutter CURIS RF GeneratorSutter Medizintechnik GmbH · 2018

Showing 5 of 10 descendants. See all descendants

Descendants cleared per year

2017: 22018: 12019: 12020: 12022: 32026: 2
2017high 3 (2022) · low 0 (2021)2026

Most influential descendants

Showing 5 of 10 · See all
  • K170107Surgi Max UltraElliquence, LLC · 2017 · cites it directly7descendants
  • K183611Soniquence RF Generator and Soniquence ElectrodesSoniquence, LLC · 2019 · 2 generations on5descendants
  • K212222Soniquence Reusable 3 Button Fingerswitch WandSoniquence, LLC · 2022 · 3 generations on1descendant
  • K202562Ellusa Generator, Ellusa Bayonet Tip, Ellusa RF-Cobb Tip, Ellusa SP-Pack and Tips…Ellusa, LLC · 2020 · 3 generations on1descendant
  • K171869Sutter CURIS RF GeneratorSutter Medizintechnik GmbH · 2018 · cites it directly1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K933157Erbotom Icc 200Erbe USA, Inc.1994—
−2K013255Surgitron 120 Iec (Also Known as Surgitron 4.0 Dual RFEllman Intl., Inc.2001—
−1K061174Surgi-MaxEllman Int'L, Inc.2006—
0 (this device)K100390Surgimax/ Surgimax PlusElliquence, LLC2010—
+1K170107Surgi Max UltraElliquence, LLC2017—
+2K183611Soniquence RF Generator and Soniquence ElectrodesSoniquence, LLC2019—
+3K212222Soniquence Reusable 3 Button Fingerswitch WandSoniquence, LLC2022—
+3K202562Ellusa Generator, Ellusa Bayonet Tip, Ellusa RF-Cobb Tip, Ellusa SP-Pack and…Ellusa, LLC2020—
+1K171869Sutter CURIS RF GeneratorSutter Medizintechnik GmbH2018—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200010

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201720
201810
201910
202010
202230
202620
FIG. 1 — Lineage of K100390, 1994–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K231790 The InMode System with the Morpheus8 Applicatorsscore 32.7 · 21 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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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.

TypeNumberDeviceApplicantDecidedRecalls
*K061174Surgi-MaxEllman Int'L, Inc.2006—

Also cleared against K061174: 2 other devices →

What descends from it? (10)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K170107Surgi Max UltraElliquence, LLC20177
K171869Sutter CURIS RF GeneratorSutter Medizintechnik GmbH20181

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 16 years and passes through 4 companies; a new generation was cleared every 4.6 years on median.
  • None of the 4 ancestors has a recall.
  • Of its descendants, K170107 (Elliquence, LLC, 2017) has gone furthest, with 7 descendants of its own.
  • 2 other devices also cite its predicate K061174.

How does its category compare?

All GEI devices

GEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.

FDA decisions per year · GEI

52in 2025

2007: 502008: 612009: 422010: 462011: 352012: 392013: 482014: 492015: 472016: 642017: 522018: 472019: 482020: 592021: 462022: 552023: 652024: 592025: 522026 (partial year): 43
2007high 65 (2023) · low 35 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GEI

113in 2025

2007: 51 days median2008: 71 days median2009: 130 days median2010: 109 days median2011: 135 days median2012: 133 days median2013: 136 days median2014: 103 days median2015: 123 days median2016: 108 days median2017: 72 days median2018: 93 days median2019: 93 days median2020: 105 days median2021: 146 days median2022: 150 days median2023: 104 days median2024: 125 days median2025: 113 days median2026 (partial year): 183 days median
2007high 183 (2026) · low 51 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · GEI

4in 2025

2007: 212008: 192009: 272010: 512011: 322012: 302013: 132014: 32015: 42016: 32017: 22018: 62019: 52020: 12021: 62022: 492023: 27, 4 Class I2024: 22, 10 Class I2025: 42026 (partial year): 8
2007high 51 (2010) · low 1 (2020)2026

Class I (14 since 2007) Class II/III not classified

Adverse event reports per year · GEI

7,592in 2025

2007: 2,7952008: 2,5562009: 3,5912010: 3,3772011: 4,4632012: 5,2162013: 4,8972014: 4,9082015: 4,9362016: 5,6162017: 6,0732018: 6,5452019: 7,0672020: 6,4902021: 6,3542022: 6,1032023: 7,1762024: 7,8972025: 7,592
2007high 7,897 (2024) · low 2,556 (2008)2025

MAUDE reports naming product code GEI, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20075051212,795
20086171192,556
200942130273,591
201046109513,377
201135135324,463
201239133305,216
201348136134,897
20144910334,908
20154712344,936
20166410835,616
2017527226,073
2018479366,545
2019489357,067
20205910516,490
20214614666,354
202255150496,103
20236510427 (4)7,176
20245912522 (10)7,897
20255211347,592
2026431838—

What is it indicated for?

Orthopedic. arthroscopic. spinal. and neurosurvical For resection, ablation, and coagulation of soft tissues and hemnostasis of blood vessels in orthopedic, arthroseopic, 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 (RAUIP), myringaotorny with effective…

Read the full statement (153 words)

Orthopedic. arthroscopic. spinal. and neurosurvical

For resection, ablation, and coagulation of soft tissues and hemnostasis of blood vessels in orthopedic, arthroseopic, 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 (RAUIP), myringaotorny with effective hemorrhage control, epistaxis treatment, and turbinate shrinkage, skin incisions, biopsy, cysts, abscesses, tumnors, cosmetic repairs, development of skin flaps, skin tags, Blepharoplasty.

Blended Cutting and Coagulation

Snoring, Submucosal palatal shrinkage, traditional uvulopalatoplasty (RAUP), myringotormy with effective hemorrhage control. epistaxis treatment, and turbinate shrinkage, skin tags, papillomna ](eloids, Keratosis, Vcrrucae. Basal CellCarcinomLa Nevi, Fistulas, Epithelionma, Cosmetic Repairs, Cysts, Abscesses, Development of skin flaps.

H-einostasis and Nonablative Coaguilation

Control of bleeding, Epilation, Telangiectasia

Bipolar

Pinpoint, Precise Coagulation, Pinpoint Hernostasis. in any field (wet or dry), snoring, submucosal palatal shrinkage, traditional uvulopalatoplasty (RAUP), myringotomy with effective hemorrhage control, epistaxis treatment, and turbinate shrinkage.

Indications for use as stated in the FDA summary.

Also cleared against K061174

2 other devices cite the same predicate.

  • K083352Veinwave, TC3000Newlands Clinical Trials, Ltd. · 2009
  • K082786Pulsar Generator, Peak Plasmablade; 4.0, Needle, and Ext Tissue Dissection DevicesPeak Surgical, Inc. · 20081 recall

More from Elliquence, LLC

8 FDA decisions under this applicant name. See the company

  • K243739AxCess® Expandable Interbody SystemElliquence, LLC · 2025
  • K180766Endiscope, Endiscope CervicalElliquence, LLC · 2018
  • K170107Surgi Max UltraElliquence, LLC · 2017
  • K162490Disc-FX SystemElliquence, LLC · 2017
  • K160041Cobbra RF Tissue DissectorElliquence, LLC · 2016

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The GEI category page

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https://510kreport.com/device/K100390 · printed Nov 6, 2026

Cite this page

510(k) Report. “K100390: Surgimax/ Surgimax Plus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100390

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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