510(k) Report

510(k) · Cleared

Cleared

Sugitron Model: Iec

K980177510(k) TraditionalCleared Jul 7, 1998168-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 Intl., Inc. · GEI Electrosurgical, Cutting & Coagulation & Accessories

Cleared on Jul 7, 1998 after a 168-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 10 later devices descend from it.

Decided
Jul 7, 1998
Review
168 days
Class
Class II
Product code
GEI
Recalls
None
Predicates
0

10 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 1999: 2 descendants cleared2002: 2 descendants cleared2005: 1 descendant cleared2011: 2 descendants cleared2012: 1 descendant cleared2014: 1 descendant cleared2020: 1 descendant cleared1995200020052010201520202025
  1. This deviceK980177 Sugitron Model: IecEllman Intl., Inc. · 1998
  2. Descendant · cites it directly · 7 of its ownK992382 Surgitron RadiolaseEllman Intl., Inc. · 1999
  3. Descendant · 2 generations on · 5 of its ownK014216 Secca SystemCuron Medical, Inc. · 2002
  4. Descendant · 3 generations on · 3 of its ownK110143 Het Bipolar Electrocautery ForcepsHet Systems, LLC · 2011
  5. Descendant · 4 generations on · 2 of its ownK121085 Het Bipolar Ligator SystemHet Systems, LLC · 2012
  6. Descendant · 5 generations on · 1 of its ownK140422 Het Systems, LLC, Het Bipolar Ligator SystemHet Systems, LLC · 2014

Showing 5 of 10 descendants. See all descendants

Descendants cleared per year

1999: 22002: 22005: 12011: 22012: 12014: 12020: 1
1999high 2 (1999) · low 0 (2000)2026

Most influential descendants

Showing 5 of 10 · See all
  • K992382Surgitron RadiolaseEllman Intl., Inc. · 1999 · cites it directly7descendants
  • K014216Secca SystemCuron Medical, Inc. · 2002 · 2 generations on5descendants
  • K110143Het Bipolar Electrocautery ForcepsHet Systems, LLC · 2011 · 3 generations on3descendants
  • K121085Het Bipolar Ligator SystemHet Systems, LLC · 2012 · 4 generations on2descendants
  • K140422Het Systems, LLC, Het Bipolar Ligator SystemHet Systems, LLC · 2014 · 5 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K980177Sugitron Model: IecEllman Intl., Inc.1998—
+1K992382Surgitron RadiolaseEllman Intl., Inc.1999—
+2K014216Secca SystemCuron Medical, Inc.2002—
+3K110143Het Bipolar Electrocautery ForcepsHet Systems, LLC2011—
+4K121085Het Bipolar Ligator SystemHet Systems, LLC2012—
+5K140422Het Systems, LLC, Het Bipolar Ligator SystemHet Systems, LLC2014—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199920
200220
200510
201120
201210
201410
202010
FIG. 1 — Lineage of K980177, 1998–2020Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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

Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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
*—Surgitron
Named without a submission number
—

What descends from it? (10)

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

NumberDeviceApplicantDecidedDescendants
K992382Surgitron RadiolaseEllman Intl., Inc.19997
K020408System 2000 Controller, System 5000 Controller, Footswitch, Power Cord, and Visage WandsffArthrocare Corp.20020
K993112Xomed Ent RF SystemXomed, Inc.19990

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?

  • Of its descendants, K992382 (Ellman Intl., Inc., 1999) has gone furthest, with 7 descendants of its own.

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?

is idendical to the Surgitron as a preammendment device such as: * Cutting Skin Incisions, Biopsy, Cysts, Abscesses, Tumors, Cosmetic Repairs, Development of Skin Flaps, SkinTags, Nevi, Keratosis, Oculoplastic Procedures, Blepharoplasty, Aponeurotic Repair, Levator Resection, Arthroscopic Procedures. * Blended Cutting and Coagulation Skin Tags, Papilloma Keloids, Keratosis, Verrucae, Basal CellCarcinoma, Neévi, Fistulas, Epithelioma, Cosmetic Repairs…

Read the full statement (96 words)

is idendical to the Surgitron as a preammendment device such as:

* Cutting

Skin Incisions, Biopsy, Cysts, Abscesses, Tumors, Cosmetic Repairs, Development of Skin Flaps, SkinTags, Nevi, Keratosis, Oculoplastic Procedures, Blepharoplasty, Aponeurotic Repair, Levator Resection, Arthroscopic Procedures.

* Blended Cutting and Coagulation

Skin Tags, Papilloma Keloids, Keratosis, Verrucae, Basal CellCarcinoma, Neévi, Fistulas, Epithelioma, Cosmetic Repairs, Cysts, Abscesses, Development of Skin Flaps, Oculoplastic Procedures, Arthroscopic Procedures.

* Hemostasis

Control of Bleeding, Epilation, Telangiectasia

* Fulguration

Basal Cell Carcinoma, Papilloma, Cyst Destruction, Tumors, Verrucae, Hemostasis.

* Bipolar

Pinpoint, Precise Coagulation, Pinpoint Hemostasis in any field (Wet or Dry).

Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.

More from Ellman Intl., Inc.

15 FDA decisions under this applicant name. See the company

  • K013255Surgitron 120 Iec (Also Known as Surgitron 4.0 Dual RFEllman Intl., Inc. · 2001
  • K003126Bipolar Trigger-Flex ProbeEllman Intl., Inc. · 2001
  • K001986Surgitron Iec IIEllman Intl., Inc. · 2000
  • K001407Surgitron Iec IIEllman Intl., Inc. · 2000
  • K001253Surgitron Iec IIEllman Intl., Inc. · 2000

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https://510kreport.com/device/K980177 · printed Nov 5, 2026

Cite this page

510(k) Report. “K980177: Sugitron Model: Iec.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K980177

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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