510(k) Report

510(k) · Cleared

Cleared

Stellartech 100 Coagulation System

K061544510(k) TraditionalCleared Oct 13, 2006130-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

Stellartech Research Corp. · GEI Electrosurgical, Cutting & Coagulation & Accessories

Cleared on Oct 13, 2006 as substantially equivalent to K994173 (Stellartech Research Corp., 2000) and 10 other predicates after a 130-day review. Its family tree reaches back 8 generations to 1995.

Decided
Oct 13, 2006
Review
130 days
Class
Class II
Product code
GEI
Recalls
None
Predicates
11

Its longest line of descent runs back 8 generations to K942299 (1995). 80 ancestors in all, the oldest K800617 (1980). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2006: 1 other ancestor2005: 2 other ancestors2003: 1 other ancestor2002: 3 other ancestors2000: 4 other ancestors1998: 7 other ancestors1997: 16 other ancestors2004: 2 other ancestors2001: 6 other ancestors1999: 3 other ancestors1996: 8 other ancestors1995: 7 other ancestors1994: 3 other ancestors1992: 2 other ancestors1984: 1 other ancestor1988: 1 other ancestor1986: 1 other ancestor1985: 1 other ancestor1981: 1 other ancestor1980: 1 other ancestor1991: 1 other ancestorK942299 · Endocare Cryotherapy System · Cytocare, Inc. · 1995K963826 · Endocare Crycare Cryosurgical System · Endocare, Inc. · 1996K973686 · Endocare Cryocare Cryosurgical System · Endocare, Inc. · 1997K980110 · Endocre Cryocare Cryosurgical System · Endocare, Inc. · 1998K011722 · Atricure Bipolar Coagulation System · AtriCure, Inc. · 2001K020919 · Atricure Bipolar System, Models ASU1, ASU2, ASU3, LHP1, LHP2, RHP1 · AtriCure, Inc. · 2002K031247 · Cardioblate Bipolar Radiofrequency Surgical Ablation System · Medtronic Vascular · 2003K060400 · Cardioblate Surgical Ablation Generator, Model 68000; Cardioblate BP2 Surgical Ablation Device, Model 60831; Cardioblat · Medtronic, Inc. · 2006198019851990199520002005
Other ancestors, by generation 1 generation back: 9 other ancestors2 generations back: 31 other ancestors3 generations back: 20 other ancestors4 generations back: 12 other ancestors K060400 · Cardioblate Surgical Ablation Generator, Model 68000; Cardioblate BP2 Surgical Ablation Device, Model 60831; Cardioblat · Medtronic, Inc. · 2006K031247 · Cardioblate Bipolar Radiofrequency Surgical Ablation System · Medtronic Vascular · 2003K020919 · Atricure Bipolar System, Models ASU1, ASU2, ASU3, LHP1, LHP2, RHP1 · AtriCure, Inc. · 2002K011722 · Atricure Bipolar Coagulation System · AtriCure, Inc. · 2001K980110 · Endocre Cryocare Cryosurgical System · Endocare, Inc. · 1998K973686 · Endocare Cryocare Cryosurgical System · Endocare, Inc. · 1997K963826 · Endocare Crycare Cryosurgical System · Endocare, Inc. · 1996K942299 · Endocare Cryotherapy System · Cytocare, Inc. · 1995−50
  1. Root · 8 generations backK942299 Endocare Cryotherapy SystemCytocare, Inc. · 1995
  2. 7 generations backK963826 Endocare Crycare Cryosurgical SystemEndocare, Inc. · 1996
  3. 6 generations backK973686 Endocare Cryocare Cryosurgical SystemEndocare, Inc. · 1997
  4. 5 generations backK980110 Endocre Cryocare Cryosurgical SystemEndocare, Inc. · 1998
  5. 4 generations backK011722 Atricure Bipolar Coagulation SystemAtriCure, Inc. · 2001
  6. 3 generations backK020919 Atricure Bipolar System, Models ASU1, ASU2, ASU3, LHP1, LHP2, RHP1AtriCure, Inc. · 2002
  7. 2 generations backK031247 Cardioblate Bipolar Radiofrequency Surgical Ablation SystemMedtronic Vascular · 2003
  8. 1 generation backK060400 Cardioblate Surgical Ablation Generator, Model 68000; Cardioblate…Medtronic, Inc. · 2006
  9. This deviceK061544 Stellartech 100 Coagulation SystemStellartech Research Corp. · 2006
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−8K942299Endocare Cryotherapy SystemCytocare, Inc.1995—
−7K963826Endocare Crycare Cryosurgical SystemEndocare, Inc.1996—
−6K973686Endocare Cryocare Cryosurgical SystemEndocare, Inc.1997—
−5K980110Endocre Cryocare Cryosurgical SystemEndocare, Inc.1998—
−4K011722Atricure Bipolar Coagulation SystemAtriCure, Inc.2001—
−3K020919Atricure Bipolar System, Models ASU1, ASU2, ASU3, LHP1, LHP2, RHP1AtriCure, Inc.2002—
−2K031247Cardioblate Bipolar Radiofrequency Surgical Ablation SystemMedtronic Vascular2003—
−1K060400Cardioblate Surgical Ablation Generator, Model 68000; Cardioblate BP2 Surgical…Medtronic, Inc.2006—
0 (this device)K061544Stellartech 100 Coagulation SystemStellartech Research Corp.2006—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198010
198110
198410
198510
198610
198810
199110
199220
199430
199570
199680
1997160
199870
199930
200040
200160
200230
200310
200420
200520
200610
FIG. 1 — Lineage of K061544, 1995–2006Source: 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? (11)

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
*K994173Stellartech Radiofrequency Generator,Model 1025A-115, Stellartech Radiofrequency…
Summary page 1
…) B. Predicate Devices Device Premarket Notification Stellartech RE Generator, K9941 73, 01/20/2000 Models #1025A- 115 & 1025A-230 Stellartech Coagulation Generator, K023765, 11/29/…
Stellartech Research Corp.2000—
*K023765Stellartech Coagulation System (Models 1100C-115 & 1100C-230)
Summary page 1
…ellartech RE Generator, K9941 73, 01/20/2000 Models #1025A- 115 & 1025A-230 Stellartech Coagulation Generator, K023765, 11/29/2002 Models # 1IOOC-115 & Il100C-230 VNUS Closure System K974521, 02/20…
Stellartech Research Corp.2002—
*K974521Vnus Closure System
Summary page 1
…ellartech Coagulation Generator, K023765, 11/29/2002 Models # 1IOOC-115 & Il100C-230 VNUS Closure System K974521, 02/20/1998 Stellartech Coagulation Probe K032062, 07/29/2003 Boston Scientific Tissue C…
Vnus Medical Technologies, Inc.1998—
*K032062Stellartech Coagulation System, Models (1100C-115 & 1100C-230)
Summary page 1
…dels # 1IOOC-115 & Il100C-230 VNUS Closure System K974521, 02/20/1998 Stellartech Coagulation Probe K032062, 07/29/2003 Boston Scientific Tissue Coagulation System K981981, 09/03/1999 Cobra Surgical Probe…
Stellartech Research Corp.2003—
*K981981Electrosurgical Unit (Esu) (115 Volt) Model 4810, Electrosurgical Unit (Esu) (230 Volt)…
Summary page 1
…K974521, 02/20/1998 Stellartech Coagulation Probe K032062, 07/29/2003 Boston Scientific Tissue Coagulation System K981981, 09/03/1999 Cobra Surgical Probe Boston Scientific Corp. Microvasive Gold K970278, 04/11/1997…
Boston Scientific Corp1998—
*K970278Microvasive Gold Probe
Summary page 1
…Boston Scientific Tissue Coagulation System K981981, 09/03/1999 Cobra Surgical Probe Boston Scientific Corp. Microvasive Gold K970278, 04/11/1997 Probe Model VIO 300 D, Erbe VIO Electrosurgical K060484, 03/16/2006 Unit…
Boston Scientific Corp1997—
*K060484Erbe Vio Esu, Model Vio 300 D
Summary page 1
…rgical Probe Boston Scientific Corp. Microvasive Gold K970278, 04/11/1997 Probe Model VIO 300 D, Erbe VIO Electrosurgical K060484, 03/16/2006 Unit Medtronic Cardioblate System K060400, 02/28/2006 Aura 70 Wa…
Erbe USA, Inc.2006—
*K060400Cardioblate Surgical Ablation Generator, Model 68000; Cardioblate BP2 Surgical Ablation…
Summary page 1
…Probe Model VIO 300 D, Erbe VIO Electrosurgical K060484, 03/16/2006 Unit Medtronic Cardioblate System K060400, 02/28/2006 Aura 70 Watt Bipolar Electrosurgical Coagulator K052203,…
Medtronic, Inc.2006—
*K052203Aura 70 Watt Bipolar Electrosurgical Coagulators, Models 28-2000 and 28-2600
Summary page 1
…ic Cardioblate System K060400, 02/28/2006 Aura 70 Watt Bipolar Electrosurgical Coagulator K052203, 10/20/2005 Estech Cobra Surgical System KO051749, 09/13/2005 AtriCure Bipolar Coagula…
Kirwan Surgical Products, Inc.2005—
*K051749Cobra Surgical System
Summary page 1
…att Bipolar Electrosurgical Coagulator K052203, 10/20/2005 Estech Cobra Surgical System KO051749, 09/13/2005 AtriCure Bipolar Coagulation System K01 1722, 08/30/2001 Subject Device,K014NA…
Estech, Inc.2005—
*K011722Atricure Bipolar Coagulation System
Summary page 1
…K052203, 10/20/2005 Estech Cobra Surgical System KO051749, 09/13/2005 AtriCure Bipolar Coagulation System K01 1722, 08/30/2001 Subject Device,K014NA Stellartech 100 Coagulation SystemK6154N/ C. Device Description:…
AtriCure, Inc.2001—

Also cleared against K994173: 2 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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 11 years and passes through 6 companies; a new generation was cleared every 1.2 years on median.
  • 3 of the 80 ancestors have a recall of any class.
  • 2 other devices also cite its predicate K994173.

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?

The Stellartech 100 Coagulation System is intended for coagulating soft tissue during open (non-laparoscopic or non-endoscopic) general surgical procedures. The System may also be used to coagulate blood and soft tissue to produce hemostasis.

Indications for use as stated in the FDA summary.

Also cleared against K994173

2 other devices cite the same predicate.

  • K023765Stellartech Coagulation System (Models 1100C-115 & 1100C-230)Stellartech Research Corp. · 2002
  • K013139Stellartech Coagulation SystemStellartech Research Corp. · 2001

More from Stellartech Research Corp.

11 FDA decisions under this applicant name. See the company

  • K050831Stellartech Coagulation System 2, Models 1100C-115A and 1100C-230AStellartech Research Corp. · 2005
  • K042909Stellartech Coagulation System, Models 1100C-115A & 1100C-230AStellartech Research Corp. · 2004
  • K041383Stellartech Coagulation System, Models 1100C-115 and 1100C-230Stellartech Research Corp. · 2004
  • K040240Stellartech Coagulation System (Models 1100C-115 & 1100C-230)Stellartech Research Corp. · 2004
  • K032721Modification to: Stellartech Coagulation System (Models 1100C-115 & 1100C-230)Stellartech Research Corp. · 2003

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The GEI category page

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https://510kreport.com/device/K061544 · printed Nov 5, 2026

Cite this page

510(k) Report. “K061544: Stellartech 100 Coagulation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K061544

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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