510(k) Report

510(k) · Cleared

Cleared

Surgi-Max

K061174510(k) TraditionalCleared Jun 28, 200662-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

Ellman Int'L, Inc. · GEI Electrosurgical, Cutting & Coagulation & Accessories

Cleared on Jun 28, 2006 as substantially equivalent to K013255 (Ellman Intl., Inc., 2001) after a 62-day review. Its family tree reaches back 2 generations to 1994. 35 later devices descend from it.

Decided
Jun 28, 2006
Review
62 days
Class
Class II
Product code
GEI
Recalls
None
Predicates
1

Its longest line of descent runs back 2 generations to K933157 (1994). 3 ancestors in all. 35 later devices descend from it, 3 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2000: 1 other ancestor2010: 4 descendants cleared2008: 1 descendant cleared2009: 1 descendant cleared2012: 2 descendants cleared2014: 4 descendants cleared2016: 2 descendants cleared2015: 2 descendants cleared2018: 2 descendants cleared2013: 1 descendant cleared2021: 1 descendant cleared2017: 3 descendants cleared2020: 3 descendants cleared2019: 1 descendant cleared2026: 2 descendants cleared2025: 2 descendants cleared2022: 3 descendants cleared2024: 1 descendant clearedK933157 · Erbotom Icc 200 · Erbe USA, Inc. · 1994K013255 · Surgitron 120 Iec (Also Known as Surgitron 4.0 Dual RF · Ellman Intl., Inc. · 20011990200020102020
Other ancestors, by generationDescendants, by generation 2 generations back: 1 other ancestor 1 generation forward: 3 descendants2 generations forward: 12 descendants3 generations forward: 9 descendants4 generations forward: 8 descendants5 generations forward: 3 descendants K013255 · Surgitron 120 Iec (Also Known as Surgitron 4.0 Dual RF · Ellman Intl., Inc. · 2001K933157 · Erbotom Icc 200 · Erbe USA, Inc. · 19940+5
  1. Root · 2 generations backK933157 Erbotom Icc 200Erbe USA, Inc. · 1994
  2. 1 generation backK013255 Surgitron 120 Iec (Also Known as Surgitron 4.0 Dual RFEllman Intl., Inc. · 2001
  3. This deviceK061174 Surgi-MaxEllman Int'L, Inc. · 2006
  4. Descendant · cites it directly · 24 of its ownK082786 Pulsar Generator, Peak Plasmablade; 4.0, Needle, and Ext Tissue…Peak Surgical, Inc. · 2008 · Recalled
  5. Descendant · cites it directly · 10 of its ownK100390 Surgimax/ Surgimax PlusElliquence, LLC · 2010
  6. Descendant · 2 generations on · 8 of its ownK093695 Peak Plasmablade 3.OS Tissue Dissection DevicePeak Surgical, Inc. · 2010
  7. Descendant · 2 generations on · 7 of its ownK170107 Surgi Max UltraElliquence, LLC · 2017
  8. Descendant · 2 generations on · 7 of its ownK142410 Elliquence ElectrodesElliquence, LLC · 2015

Showing 5 of 35 descendants. See all descendants

Descendants cleared per year

2008: 12009: 12010: 42012: 22013: 12014: 42015: 22016: 22017: 32018: 22019: 12020: 32021: 12022: 32024: 12025: 22026: 2
2008high 4 (2010) · low 0 (2011)2026

Most influential descendants

Showing 5 of 35 · See all
  • K082786Pulsar Generator, Peak Plasmablade; 4.0, Needle, and Ext Tissue Dissection DevicesPeak Surgical, Inc. · 2008 · cites it directly24descendants
  • K100390Surgimax/ Surgimax PlusElliquence, LLC · 2010 · cites it directly10descendants
  • K093695Peak Plasmablade 3.OS Tissue Dissection DevicePeak Surgical, Inc. · 2010 · 2 generations on8descendants
  • K170107Surgi Max UltraElliquence, LLC · 2017 · 2 generations on7descendants
  • K142410Elliquence ElectrodesElliquence, LLC · 2015 · 2 generations on7descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K933157Erbotom Icc 200Erbe USA, Inc.1994—
−1K013255Surgitron 120 Iec (Also Known as Surgitron 4.0 Dual RFEllman Intl., Inc.2001—
0 (this device)K061174Surgi-MaxEllman Int'L, Inc.2006—
+1K082786Pulsar Generator, Peak Plasmablade; 4.0, Needle, and Ext Tissue Dissection…Peak Surgical, Inc.20081
+1K100390Surgimax/ Surgimax PlusElliquence, LLC2010—
+2K093695Peak Plasmablade 3.OS Tissue Dissection DevicePeak Surgical, Inc.2010—
+2K170107Surgi Max UltraElliquence, LLC2017—
+2K142410Elliquence ElectrodesElliquence, LLC2015—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200010

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200810
200910
201040
201220
201310
201440
201520
201620
201730
201820
201910
202030
202110
202230
202410
202520
202620
FIG. 1 — Lineage of K061174, 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
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K013255Surgitron 120 Iec (Also Known as Surgitron 4.0 Dual RF
Summary page 4
…th IEC 60601-1 and IEC 60601-2-2. Predicate Device 121 CFR 807.92(a)(3)] The predicate devices are listed as follows: a Ellman Surgitron LEC 120 /4.0 DU - K013255 Conclusion 121 CFR 807.92(b)(3)] We believe the differences between the subject device and predicate device are minor and co…
Ellman Intl., Inc.2001—

Also cleared against K013255: 5 other devices →

What descends from it? (35)

See all 35

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

NumberDeviceApplicantDecidedDescendants
K082786Pulsar Generator, Peak Plasmablade; 4.0, Needle, and Ext Tissue Dissection DevicesPeak Surgical, Inc.200824
K100390Surgimax/ Surgimax PlusElliquence, LLC201010
K083352Veinwave, TC3000Newlands Clinical Trials, Ltd.20094

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 12 years and passes through 3 companies; a new generation was cleared every 7.7 years on median.
  • None of the 3 ancestors has a recall.
  • Of its descendants, K082786 (Peak Surgical, Inc., 2008) has gone furthest, with 24 descendants of its own.
  • 5 other devices also cite its predicate K013255.

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.

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 neurosurgical 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 neurosurgical

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 Coamilation

Snoring, Submucsal 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 Coaizulation

Control of bleeding, Epilation, Telangiectasia

Bipolar

Pinpoint, Precise Coagulation, Pinpoint Hemostasis, 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 K013255

5 other devices cite the same predicate.

  • K200931RF Surgical GeneratorFulwell, LLC · 2020
  • K123366Surgitron 4.0 Dual RF S5-IecEllman International, Inc. · 20131 recall
  • K082834Ellman International Non-Ablative Technique for Surgitron IecEllman Int'L, Inc. · 20091 recall
  • K073057Pulsar Generator, Model PS100-100, and Peak Plasmablade Tissue Dissection Device, Model PS200-040Peak Surgical, Inc. · 2008
  • K051956DR. Oppel ST-501Sometech Incorporated · 2005

More from Ellman Int'L, Inc.

6 FDA decisions under this applicant name. See the company

  • K102698Pelleve Glidesafe Non-Ablative Wrinkle Treatment System Model Pelleve GlidesafeEllman Int'L, Inc. · 2011
  • K102368Non-Ablative Wrinkle Treatment HandpieceEllman Int'L, Inc. · 2010
  • K101967Non-Ablative Wrinkle Treatent Handpiece Modle Pelleve'Ellman Int'L, Inc. · 2010
  • K082834Ellman International Non-Ablative Technique for Surgitron IecEllman Int'L, Inc. · 20091 recall
  • K042710Surgitron Radiolase IIEllman Int'L, Inc. · 2005

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The GEI category page

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https://510kreport.com/device/K061174 · printed Nov 4, 2026

Cite this page

510(k) Report. “K061174: Surgi-Max.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K061174

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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