510(k) Report

510(k) · Cleared

Cleared

Stellartech Coagulation System 2, Models 1100C-115A and 1100C-230A

K050831510(k) SpecialCleared Apr 12, 200511-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 Apr 12, 2005 as substantially equivalent to K013139 (Stellartech Research Corp., 2001) and 7 other predicates after an 11-day review. Its family tree reaches back 12 generations to 1995. 34 later devices descend from it.

Decided
Apr 12, 2005
Review
11 days
Class
Class II
Product code
GEI
Recalls
None
Predicates
8

Its longest line of descent runs back 12 generations to K943450 (1995). 29 ancestors in all, the oldest K800617 (1980). 34 later devices descend from it, 5 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2002: 1 other ancestor2000: 1 other ancestor1998: 2 other ancestors1997: 1 other ancestor1996: 5 other ancestors1994: 1 other ancestor1992: 1 other ancestor1984: 1 other ancestor1986: 1 other ancestor1985: 1 other ancestor1980: 1 other ancestor1995: 1 other ancestor2006: 4 descendants cleared2010: 3 descendants cleared2008: 2 descendants cleared2009: 3 descendants cleared2019: 2 descendants cleared2007: 1 descendant cleared2012: 2 descendants cleared2014: 2 descendants cleared2013: 1 descendant cleared2015: 1 descendant cleared2017: 2 descendants cleared2018: 2 descendants cleared2016: 2 descendants cleared2024: 2 descendants cleared2021: 3 descendants cleared2025: 1 descendant cleared2020: 1 descendant clearedK943450 · Arthrocare Arthroscopic Electrosurgery System Model 970 · Arthrocare Corp. · 1995×2: 2 generations cleared close together, K961069 (1996), K962445 (1996) ×2: 2 generations cleared close together, K964849 (1997), K971532 (1997) K013139 · Stellartech Coagulation System · Stellartech Research Corp. · 2001×3: 3 generations cleared close together, K032062 (2003), K032452 (2003), K032721 (2003) ×3: 3 generations cleared close together, K040240 (2004), K041383 (2004), K042909 (2004) 19801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor2 generations back: 8 other ancestors3 generations back: 5 other ancestors4 generations back: 3 other ancestors 1 generation forward: 5 descendants2 generations forward: 9 descendants3 generations forward: 12 descendants4 generations forward: 2 descendants5 generations forward: 2 descendants6 generations forward: 1 descendant7 generations forward: 1 descendant8 generations forward: 1 descendant9 generations forward: 1 descendant K042909 · Stellartech Coagulation System, Models 1100C-115A & 1100C-230A · Stellartech Research Corp. · 2004K041383 · Stellartech Coagulation System, Models 1100C-115 and 1100C-230 · Stellartech Research Corp. · 2004K040240 · Stellartech Coagulation System (Models 1100C-115 & 1100C-230) · Stellartech Research Corp. · 2004K032721 · Modification to: Stellartech Coagulation System (Models 1100C-115 & 1100C-230) · Stellartech Research Corp. · 2003K032452 · Modification to: Stellartech Coagulation System, Models 1100C-115 & 100C-230 · Stellartech Research Corp. · 2003K032062 · Stellartech Coagulation System, Models (1100C-115 & 1100C-230) · Stellartech Research Corp. · 2003K013139 · Stellartech Coagulation System · Stellartech Research Corp. · 2001K971532 · Arthrocare Electrosurgery System · Arthrocare Corp. · 1997K964849 · Arthrocare Dermatologic Electrosurgery System · Arthrocare Corp. · 1997K962445 · Arthrocare Dental Electrosurgery System · Arthrocare Corp. · 1996K961069 · Arthrocare Urologic Multi-Electrode Electrosurgery System · Arthrocare Corp. · 1996K943450 · Arthrocare Arthroscopic Electrosurgery System Model 970 · Arthrocare Corp. · 1995−10−50+5
  1. Root · 12 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
  2. 8 generations between
  3. 3 generations backK040240 Stellartech Coagulation System (Models 1100C-115 & 1100C-230)Stellartech Research Corp. · 2004
  4. 2 generations backK041383 Stellartech Coagulation System, Models 1100C-115 and 1100C-230Stellartech Research Corp. · 2004
  5. 1 generation backK042909 Stellartech Coagulation System, Models 1100C-115A & 1100C-230AStellartech Research Corp. · 2004
  6. This deviceK050831 Stellartech Coagulation System 2, Models 1100C-115A and 1100C-230AStellartech Research Corp. · 2005
  7. Descendant · cites it directly · 29 of its ownK060169 Barrx Halo Coagulation System, Barrx Halo Coagulation Generator…Barrx Medical, Incorporated · 2006
  8. Descendant · 2 generations on · 26 of its ownK062723 HALO90 Coagulation CatheterBarrx Medical, Incorporated · 2006
  9. Descendant · 3 generations on · 22 of its ownK083737 Halo Ablation CatheterBarrx Medical, Incorporated · 2009
  10. Descendant · cites it directly · 20 of its ownK062225 Halo Coagulation CatheterBarrx Medical, Incorporated · 2006
  11. Descendant · 2 generations on · 19 of its ownK071543 HALO360' Coagulation CatheterBarrx Medical, Incorporated · 2007
Show all 12 generations
  1. Root · 12 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
  2. 11 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
  3. 10 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
  4. 9 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
  5. 8 generations backK971532 Arthrocare Electrosurgery SystemArthrocare Corp. · 1997
  6. 7 generations backK013139 Stellartech Coagulation SystemStellartech Research Corp. · 2001
  7. 6 generations backK032062 Stellartech Coagulation System, Models (1100C-115 & 1100C-230)Stellartech Research Corp. · 2003
  8. 5 generations backK032452 Modification to: Stellartech Coagulation System, Models 1100C-115 &…Stellartech Research Corp. · 2003
  9. 4 generations backK032721 Modification to: Stellartech Coagulation System (Models 1100C-115 &…Stellartech Research Corp. · 2003
  10. 3 generations backK040240 Stellartech Coagulation System (Models 1100C-115 & 1100C-230)Stellartech Research Corp. · 2004
  11. 2 generations backK041383 Stellartech Coagulation System, Models 1100C-115 and 1100C-230Stellartech Research Corp. · 2004
  12. 1 generation backK042909 Stellartech Coagulation System, Models 1100C-115A & 1100C-230AStellartech Research Corp. · 2004
  13. This deviceK050831 Stellartech Coagulation System 2, Models 1100C-115A and 1100C-230AStellartech Research Corp. · 2005

Showing 5 of 34 descendants. See all descendants

Descendants cleared per year

2006: 42007: 12008: 22009: 32010: 32012: 22013: 12014: 22015: 12016: 22017: 22018: 22019: 22020: 12021: 32024: 22025: 1
2006high 4 (2006) · low 0 (2011)2026

Most influential descendants

Showing 5 of 34 · See all
  • K060169Barrx Halo Coagulation System, Barrx Halo Coagulation Generator, Barrx Coagulation…Barrx Medical, Incorporated · 2006 · cites it directly29descendants
  • K062723HALO90 Coagulation CatheterBarrx Medical, Incorporated · 2006 · 2 generations on26descendants
  • K083737Halo Ablation CatheterBarrx Medical, Incorporated · 2009 · 3 generations on22descendants
  • K062225Halo Coagulation CatheterBarrx Medical, Incorporated · 2006 · cites it directly20descendants
  • K071543HALO360' Coagulation CatheterBarrx Medical, Incorporated · 2007 · 2 generations on19descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−12K943450Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp.1995—
−11K961069Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp.1996—
−10K962445Arthrocare Dental Electrosurgery SystemArthrocare Corp.1996—
−9K964849Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp.1997—
−8K971532Arthrocare Electrosurgery SystemArthrocare Corp.1997—
−7K013139Stellartech Coagulation SystemStellartech Research Corp.2001—
−6K032062Stellartech Coagulation System, Models (1100C-115 & 1100C-230)Stellartech Research Corp.2003—
−5K032452Modification to: Stellartech Coagulation System, Models 1100C-115 & 100C-230Stellartech Research Corp.2003—
−4K032721Modification to: Stellartech Coagulation System (Models 1100C-115 & 1100C-230)Stellartech Research Corp.2003—
−3K040240Stellartech Coagulation System (Models 1100C-115 & 1100C-230)Stellartech Research Corp.2004—
−2K041383Stellartech Coagulation System, Models 1100C-115 and 1100C-230Stellartech Research Corp.2004—
−1K042909Stellartech Coagulation System, Models 1100C-115A & 1100C-230AStellartech Research Corp.2004—
0 (this device)K050831Stellartech Coagulation System 2, Models 1100C-115A and 1100C-230AStellartech Research Corp.2005—
+1K060169Barrx Halo Coagulation System, Barrx Halo Coagulation Generator, Barrx…Barrx Medical, Incorporated2006—
+2K062723HALO90 Coagulation CatheterBarrx Medical, Incorporated2006—
+3K083737Halo Ablation CatheterBarrx Medical, Incorporated2009—
+1K062225Halo Coagulation CatheterBarrx Medical, Incorporated2006—
+2K071543HALO360' Coagulation CatheterBarrx Medical, Incorporated2007—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198010
198410
198510
198610
199210
199410
199510
199650
199710
199820
200010
200210

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200640
200710
200820
200930
201030
201220
201310
201420
201510
201620
201720
201820
201920
202010
202130
202420
202510
FIG. 1 — Lineage of K050831, 1995–2025Source: 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 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? (8)

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
*K013139Stellartech Coagulation System
Summary page 1
…rteriovenous Malformations, Angiomata, Barrett's Esophagus, Diculafoy Lesions, and Angiodysplasia. Special 510(k) Device Modification Notification K023765, K013139, K(032062, K032452, K032721, K040240, Pg 5o 1 1(041383, K(0402909…
Stellartech Research Corp.2001—
*K023765Stellartech Coagulation System (Models 1100C-115 & 1100C-230)
Summary page 1
…artech Coagulation System K(013139, 12/18/01 Stellartech Coagulation System K023765, 11/29/02 Stellartech Coagulation System K(032062, 07/29/03…
Stellartech Research Corp.2002—
*K032062Stellartech Coagulation System, Models (1100C-115 & 1100C-230)
Summary page 2
…System 2 is substantially equivalent to devices currently marketed in the United States. Special 510(k) Device Modification Notification K023765, K(013139, K032062, K(032452, K032721, K(040240, P 6o 1 K(041383, K(0402909…
Stellartech Research Corp.2003—
*K032452Modification to: Stellartech Coagulation System, Models 1100C-115 & 100C-230
Summary page 1
…lartech Coagulation System K(032062, 07/29/03 Stellar-tech Coagulation System K032452, 08/21/03 Stellartech Coagulation System K(032721, 10/06/03…
Stellartech Research Corp.2003—
*K032721Modification to: Stellartech Coagulation System (Models 1100C-115 & 1100C-230)
Summary page 1
…Angiomata, Barrett's Esophagus, Diculafoy Lesions, and Angiodysplasia. Special 510(k) Device Modification Notification K023765, K013139, K(032062, K032452, K032721, K040240, Pg 5o 1 1(041383, K(0402909…
Stellartech Research Corp.2003—
*K040240Stellartech Coagulation System (Models 1100C-115 & 1100C-230)
Summary page 1
…, Barrett's Esophagus, Diculafoy Lesions, and Angiodysplasia. Special 510(k) Device Modification Notification K023765, K013139, K(032062, K032452, K032721, K040240, Pg 5o 1 1(041383, K(0402909 Pg…
Stellartech Research Corp.2004—
*K041383Stellartech Coagulation System, Models 1100C-115 and 1100C-230
Summary page 5
…Concurrence of CDRH, Office of Device Evaluation (ODE) Special 510(k) Device Modification Notification K023765, K013139, K032062, K032452, K032721, K040240, K041383, K0402909 *~~~~~~~~~~~ae1<7…
Stellartech Research Corp.2004—
*K042909Stellartech Coagulation System, Models 1100C-115A & 1100C-230A
Summary page 1
…tech Coagulation System 1(041383, 06/14/04 Stellartech Coagulation System 1(042909, 11/12/04 C. Device Description: The Stellartech Coagulation System 2 consists of the following components.…
Stellartech Research Corp.2004—

Also cleared against K013139: 7 other devices →

What descends from it? (34)

See all 34

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

NumberDeviceApplicantDecidedDescendants
K060169Barrx Halo Coagulation System, Barrx Halo Coagulation Generator, Barrx Coagulation…Barrx Medical, Incorporated200629
K062225Halo Coagulation CatheterBarrx Medical, Incorporated200620
K093008Halo Ablation Catheter, Model 90-9100Barrx Medical, Incorporated201014
K062441Barrx Halo Coagulation System; Generator, Model 90-9000; Output Cable, Model 90-9010…Barrx Medical, Incorporated20063
K082202HALO360 Energy Generator, Models 1100C-115B and 1100C-230BBarrx Medical, Incorporated20080

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 10 years and passes through 2 companies; a new generation was cleared every 5 months on median.
  • 1 of the 29 ancestors has a recall of any class.
  • Of its descendants, K060169 (Barrx Medical, Incorporated, 2006) has gone furthest, with 29 descendants of its own.
  • 7 other devices also cite its predicate K013139.

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 Coagulation System 2 is indicated for use in the coagulation of bleeding and non-bleeding sites in the gastrointestinal tract including but not limited to, the esophagus. Indications include Esophageal Ulcers, Mallory-Weiss tears, Arteriovenous Malformations, Angiomata, Barrett's Esophagus, Dieulafoy Lesions, and Angiodysplasia.

Indications for use as stated in the FDA summary.

Also cleared against K013139

7 other devices cite the same predicate.

  • K093008Halo Ablation Catheter, Model 90-9100Barrx Medical, Incorporated · 2010
  • 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
  • K032452Modification to: Stellartech Coagulation System, Models 1100C-115 & 100C-230Stellartech Research Corp. · 2003

More from Stellartech Research Corp.

11 FDA decisions under this applicant name. See the company

  • K061544Stellartech 100 Coagulation SystemStellartech Research Corp. · 2006
  • 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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https://510kreport.com/device/K050831 · printed Nov 4, 2026

Cite this page

510(k) Report. “K050831: Stellartech Coagulation System 2, Models 1100C-115A and 1100C-230A.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K050831

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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