510(k) Report

510(k) · Cleared

Cleared

Aragon Oneshot System

K081312510(k) TraditionalCleared Oct 31, 2008175-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

Aragon Surgical, Inc. · GEI Electrosurgical, Cutting & Coagulation & Accessories

Cleared on Oct 31, 2008 as substantially equivalent to K981916 (Valleylab, Inc., 1998) and 1 other predicate after a 175-day review. Its family tree reaches back 4 generations to 1994. 10 later devices descend from it.

Decided
Oct 31, 2008
Review
175 days
Class
Class II
Product code
GEI
Recalls
None
Predicates
2

Its longest line of descent runs back 4 generations to K932293 (1994). 11 ancestors in all. 10 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2001: 2 other ancestors1996: 1 other ancestor1995: 4 other ancestors2009: 1 descendant cleared2010: 1 descendant cleared2013: 1 descendant cleared2011: 1 descendant cleared2014: 1 descendant cleared2015: 2 descendants cleared2020: 2 descendants cleared2019: 1 descendant clearedK932293 · Cabot Medical Bipolar Cutting Forceps · Cabot Medical Corp. · 1994 · recalledK981916 · Ligasure Vessel Sealing System · Valleylab, Inc. · 1998K031011 · Ligasure 5MM Laparoscopic Sealer-Divider, Model LS1500 · Valleylab, Inc. · 2003 · recalledK041587 · Ligasure Precise Model #LS1200/Ligasure 5MM Laparoscopic Sealer Divider Model # LS1500 · Valleylab · 20041990200020102020
Other ancestors, by generationDescendants, by generation 2 generations back: 6 other ancestors3 generations back: 1 other ancestor 1 generation forward: 1 descendant2 generations forward: 3 descendants3 generations forward: 3 descendants4 generations forward: 3 descendants K041587 · Ligasure Precise Model #LS1200/Ligasure 5MM Laparoscopic Sealer Divider Model # LS1500 · Valleylab · 2004K031011 · Ligasure 5MM Laparoscopic Sealer-Divider, Model LS1500 · Valleylab, Inc. · 2003 · recalledK981916 · Ligasure Vessel Sealing System · Valleylab, Inc. · 1998K932293 · Cabot Medical Bipolar Cutting Forceps · Cabot Medical Corp. · 1994 · recalled0
  1. Root · 4 generations backK932293 Cabot Medical Bipolar Cutting ForcepsCabot Medical Corp. · 1994 · Recalled
  2. 3 generations backK981916 Ligasure Vessel Sealing SystemValleylab, Inc. · 1998
  3. 2 generations backK031011 Ligasure 5MM Laparoscopic Sealer-Divider, Model LS1500Valleylab, Inc. · 2003 · Recalled
  4. 1 generation backK041587 Ligasure Precise Model #LS1200/Ligasure 5MM Laparoscopic Sealer…Valleylab · 2004
  5. This deviceK081312 Aragon Oneshot SystemAragon Surgical, Inc. · 2008
  6. Descendant · cites it directly · 9 of its ownK090306 Aragon Surgical RF System L2 InstrumentAragon Surgical, Inc. · 2009
  7. Descendant · 2 generations on · 7 of its ownK110824 Aragon Surgical RF System - 5MM Laparoscopic InstrumentAragon Surgical, Inc. · 2011
  8. Descendant · 2 generations on · 7 of its ownK093075 Aragon Surgical RF System Teleo InstrumentAragon Surgical, Inc. · 2010 · Recalled
  9. Descendant · 2 generations on · 6 of its ownK130596 Caiman Seal and Cut TechnologyAesculap, Inc. · 2013
  10. Descendant · 3 generations on · 2 of its ownK151696 Caiman Seal and Cut TechnologyAesculap, Inc. · 2015

Showing 5 of 10 descendants. See all descendants

Descendants cleared per year

2009: 12010: 12011: 12013: 12014: 12015: 22019: 12020: 2
2009high 2 (2015) · low 0 (2012)2026

Most influential descendants

Showing 5 of 10 · See all
  • K090306Aragon Surgical RF System L2 InstrumentAragon Surgical, Inc. · 2009 · cites it directly9descendants
  • K110824Aragon Surgical RF System - 5MM Laparoscopic InstrumentAragon Surgical, Inc. · 2011 · 2 generations on7descendants
  • K093075Aragon Surgical RF System Teleo InstrumentAragon Surgical, Inc. · 2010 · 2 generations on7descendants
  • K130596Caiman Seal and Cut TechnologyAesculap, Inc. · 2013 · 2 generations on6descendants
  • K151696Caiman Seal and Cut TechnologyAesculap, Inc. · 2015 · 3 generations on2descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K932293Cabot Medical Bipolar Cutting ForcepsCabot Medical Corp.19943
−3K981916Ligasure Vessel Sealing SystemValleylab, Inc.1998—
−2K031011Ligasure 5MM Laparoscopic Sealer-Divider, Model LS1500Valleylab, Inc.20032
−1K041587Ligasure Precise Model #LS1200/Ligasure 5MM Laparoscopic Sealer Divider Model…Valleylab2004—
0 (this device)K081312Aragon Oneshot SystemAragon Surgical, Inc.2008—
+1K090306Aragon Surgical RF System L2 InstrumentAragon Surgical, Inc.2009—
+2K110824Aragon Surgical RF System - 5MM Laparoscopic InstrumentAragon Surgical, Inc.2011—
+2K093075Aragon Surgical RF System Teleo InstrumentAragon Surgical, Inc.20102
+2K130596Caiman Seal and Cut TechnologyAesculap, Inc.2013—
+3K151696Caiman Seal and Cut TechnologyAesculap, Inc.2015—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199540
199610
200120

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200910
201010
201110
201310
201410
201520
201910
202020
FIG. 1 — Lineage of K081312, 1994–2020Source: 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? (2)

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
*K981916Ligasure Vessel Sealing System
Summary page 1
…evice Panel: General Surgery/Restorative Devices Device Classification: Class II PREDICATE DEVICES · LiagSure TM Vessel Sealing System (K981916) · LigaSure TM Open Dissector Divider (K041587) DEVICE DESCRIPTION The Aragon Surgical RF System consists of the Aragon…
Valleylab, Inc.1998—
*K041587Ligasure Precise Model #LS1200/Ligasure 5MM Laparoscopic Sealer Divider Model # LS1500
Summary page 1
…e Devices Device Classification: Class II PREDICATE DEVICES · LiagSure TM Vessel Sealing System (K981916) · LigaSure TM Open Dissector Divider (K041587) DEVICE DESCRIPTION The Aragon Surgical RF System consists of the Aragon Surgical Radiofrequency Energy (RF) Generator and a han…
Valleylab2004—

Also cleared against K981916: 15 other devices →

What descends from it? (10)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K090306Aragon Surgical RF System L2 InstrumentAragon Surgical, Inc.20099

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 14 years and passes through 4 companies; a new generation was cleared every 4.1 years on median.
  • 3 of the 11 ancestors have a recall of any class.
  • Of its descendants, K090306 (Aragon Surgical, Inc., 2009) has gone furthest, with 9 descendants of its own.
  • 15 other devices also cite its predicate K981916.

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. 2008, 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?

The Aragon Surgical RF System is indicated for tissue sealing and division during the performance of abdominal hysterectomy. The instrument can seal vessels up to 7mm.

This device is not effective for use in tubal sterilization/tubal coagulation for sterilization purposes.

Indications for use as stated in the FDA summary.

Also cleared against K981916

15 other devices cite the same predicate.

  • K160331LigaSure Curved Jaw, Open Sealer/Divider Electrode, LigaSure Curved Jaw Open Reusable ClampCovidien · 2016
  • K160602JustRight Surgical Vessel Sealing SystemJustright Surgical · 2016
  • K140459Altrus Thermal Tissue Fusion Energy Source, Altrus Thermal Tissue Fusion Handpiece, Altrus Thermal Tissue…Conmed Corporation · 20141 recall
  • K123662The Justright Surgical Vessel Sealing SystemJustright Surgical, LLC · 2013
  • K110824Aragon Surgical RF System - 5MM Laparoscopic InstrumentAragon Surgical, Inc. · 2011
  • K101534Conmed Altrus Thermal Tissue Fusion SystemConmedcorp · 20108 recalls

More from Aragon Surgical, Inc.

6 FDA decisions under this applicant name. See the company

  • K110824Aragon Surgical RF System - 5MM Laparoscopic InstrumentAragon Surgical, Inc. · 2011
  • K093075Aragon Surgical RF System Teleo InstrumentAragon Surgical, Inc. · 20102 recalls
  • K090306Aragon Surgical RF System L2 InstrumentAragon Surgical, Inc. · 2009
  • K073452Modification to: Aragon Surgical LapcapAragon Surgical, Inc. · 2008
  • K070651Aragon Surgical LapcapAragon Surgical, Inc. · 2007

Recent decisions in GEI

The GEI category page

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  • K261959Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, 70mm Blade, Push Button Switch…Stryker Instruments · 2026
  • K254196HARMONIC 1100 Shears (HAR1120); HARMONIC 1100 Shears (HAR1136)Ethicon Endo-Surgery, LLC · 2026
  • K261070LigaSure™ RAS Maryland Jaw Vessel Sealer/Divider, Nano-coatedCovidien, LLC · 2026
  • K254185Potenza PrimeJeisys Medical Incorporated · 2026

https://510kreport.com/device/K081312 · printed Nov 6, 2026

Cite this page

510(k) Report. “K081312: Aragon Oneshot System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K081312

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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