510(k) · Cleared
ClearedAragon Surgical RF System L2 Instrument
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aragon Surgical, Inc. · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Jun 18, 2009 as substantially equivalent to K081312 (Aragon Surgical, Inc., 2008) and 2 other predicates after a 132-day review. Its family tree reaches back 5 generations to 1994. 9 later devices descend from it.
- Decided
- Jun 18, 2009
- Review
- 132 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K932293 (1994). 12 ancestors in all. 9 later devices descend from it, 3 citing it directly.
- Root · 5 generations backK932293 Cabot Medical Bipolar Cutting ForcepsCabot Medical Corp. · 1994 · Recalled
- 4 generations backK981916 Ligasure Vessel Sealing SystemValleylab, Inc. · 1998
- 3 generations backK031011 Ligasure 5MM Laparoscopic Sealer-Divider, Model LS1500Valleylab, Inc. · 2003 · Recalled
- 2 generations backK041587 Ligasure Precise Model #LS1200/Ligasure 5MM Laparoscopic Sealer…Valleylab · 2004
- 1 generation backK081312 Aragon Oneshot SystemAragon Surgical, Inc. · 2008
- This deviceK090306 Aragon Surgical RF System L2 InstrumentAragon Surgical, Inc. · 2009
- Descendant · cites it directly · 7 of its ownK110824 Aragon Surgical RF System - 5MM Laparoscopic InstrumentAragon Surgical, Inc. · 2011
- Descendant · cites it directly · 7 of its ownK093075 Aragon Surgical RF System Teleo InstrumentAragon Surgical, Inc. · 2010 · Recalled
- Descendant · cites it directly · 6 of its ownK130596 Caiman Seal and Cut TechnologyAesculap, Inc. · 2013
- Descendant · 2 generations on · 2 of its ownK151696 Caiman Seal and Cut TechnologyAesculap, Inc. · 2015
- Descendant · 2 generations on · 1 of its ownK140839 Caiman Seal and Cut TechnologyAesculap, Inc. · 2014
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K110824Aragon Surgical RF System - 5MM Laparoscopic InstrumentAragon Surgical, Inc. · 2011 · cites it directly7descendants
- K093075Aragon Surgical RF System Teleo InstrumentAragon Surgical, Inc. · 2010 · cites it directly7descendants
- K130596Caiman Seal and Cut TechnologyAesculap, Inc. · 2013 · cites it directly6descendants
- K151696Caiman Seal and Cut TechnologyAesculap, Inc. · 2015 · 2 generations on2descendants
- K140839Caiman Seal and Cut TechnologyAesculap, Inc. · 2014 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K932293 | Cabot Medical Bipolar Cutting Forceps | Cabot Medical Corp. | 1994 | 3 |
| −4 | K981916 | Ligasure Vessel Sealing System | Valleylab, Inc. | 1998 | — |
| −3 | K031011 | Ligasure 5MM Laparoscopic Sealer-Divider, Model LS1500 | Valleylab, Inc. | 2003 | 2 |
| −2 | K041587 | Ligasure Precise Model #LS1200/Ligasure 5MM Laparoscopic Sealer Divider Model… | Valleylab | 2004 | — |
| −1 | K081312 | Aragon Oneshot System | Aragon Surgical, Inc. | 2008 | — |
| 0 (this device) | K090306 | Aragon Surgical RF System L2 Instrument | Aragon Surgical, Inc. | 2009 | — |
| +1 | K110824 | Aragon Surgical RF System - 5MM Laparoscopic Instrument | Aragon Surgical, Inc. | 2011 | — |
| +1 | K093075 | Aragon Surgical RF System Teleo Instrument | Aragon Surgical, Inc. | 2010 | 2 |
| +1 | K130596 | Caiman Seal and Cut Technology | Aesculap, Inc. | 2013 | — |
| +2 | K151696 | Caiman Seal and Cut Technology | Aesculap, Inc. | 2015 | — |
| +2 | K140839 | Caiman Seal and Cut Technology | Aesculap, Inc. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 4 | 0 |
| 1996 | 1 | 0 |
| 2001 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
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 K231790 The InMode System with the Morpheus8 Applicatorsscore 32.7 · 21 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K081312 | Aragon Oneshot SystemSummary page 1…878.4400) Device Panel: General Surgery/Restorative Devices Device Classification: Class II PREDICATE DEVICES · Aragon Surgical RF System (K081312) * LiagSure Tm Atlas Laparoscopic Sealer/Divider (KO 10013) · Valleylab LigaSure Vessel Sealing System (K981916)… | 2008 |
| * | K010013 | Ligasure Laparoscopic Sealer Divider Model LS1100 | 2001 |
| * | K981916 | Ligasure Vessel Sealing SystemSummary page 1…ICES · Aragon Surgical RF System (K081312) * LiagSure Tm Atlas Laparoscopic Sealer/Divider (KO 10013) · Valleylab LigaSure Vessel Sealing System (K981916) DEVICE DESCRIPTION The Aragon Surgical Laparoscopic Instrument(L2) is provided as a sterile, single use device. The device is… | 1998 |
What descends from it? (9)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 15 years and passes through 4 companies; a new generation was cleared every 4.1 years on median.
- 3 of the 12 ancestors have a recall of any class.
- Of its descendants, K110824 (Aragon Surgical, Inc., 2011) has gone furthest, with 7 descendants of its own.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · GEI
52in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GEI
113in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GEI
4in 2025
Class I (14 since 2007) Class II/III not classified
Adverse event reports per year · GEI
7,592in 2025
MAUDE reports naming product code GEI, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 50 | 51 | 21 | 2,795 |
| 2008 | 61 | 71 | 19 | 2,556 |
| 2009 | 42 | 130 | 27 | 3,591 |
| 2010 | 46 | 109 | 51 | 3,377 |
| 2011 | 35 | 135 | 32 | 4,463 |
| 2012 | 39 | 133 | 30 | 5,216 |
| 2013 | 48 | 136 | 13 | 4,897 |
| 2014 | 49 | 103 | 3 | 4,908 |
| 2015 | 47 | 123 | 4 | 4,936 |
| 2016 | 64 | 108 | 3 | 5,616 |
| 2017 | 52 | 72 | 2 | 6,073 |
| 2018 | 47 | 93 | 6 | 6,545 |
| 2019 | 48 | 93 | 5 | 7,067 |
| 2020 | 59 | 105 | 1 | 6,490 |
| 2021 | 46 | 146 | 6 | 6,354 |
| 2022 | 55 | 150 | 49 | 6,103 |
| 2023 | 65 | 104 | 27 (4) | 7,176 |
| 2024 | 59 | 125 | 22 (10) | 7,897 |
| 2025 | 52 | 113 | 4 | 7,592 |
| 2026 | 43 | 183 | 8 | — |
What is it indicated for?
The Aragon Surgical Laparoscopic (L2) Instrument is a dedicated bipolar electrosurgical instrument intended for use in general surgical and gynecologic laparoscopic procedures where ligation and division of vessels is desired. The instruments create a seal by the application of bipolar electrosurgical RF energy (coagulation) to vascular structure (vessels) interposed between the jaws of the device. A cutting blade is actuated for the division of tissue.…
Read the full statement (174 words)
The Aragon Surgical Laparoscopic (L2) Instrument is a dedicated bipolar electrosurgical instrument intended for use in general surgical and gynecologic laparoscopic procedures where ligation and division of vessels is desired. The instruments create a seal by the application of bipolar electrosurgical RF energy (coagulation) to vascular structure (vessels) interposed between the jaws of the device. A cutting blade is actuated for the division of tissue.
The indications for use include general laparoscopic procedures, (including urologic, vascular, thoracic, and thoracoscopic), and gynecological laparoscopic procedures where ligation and division of vessels is performed. These procedures include: vaginal hysterectomies, Nissen fundoplication, colectomy, adhesiolysis, bowel resections, and oophorectomy etc., or any procedure where vessel ligation (cutting and sealing), tissue grasping, and dissection is performed.
The device can be used on vessels up to and including 7mm and bundles as large as will fit in the jaws of the instrument.
The Aragon Surgical Laparoscopic Instrument has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures. Do not use the system for these procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090306 · printed Nov 6, 2026
Cite this page
510(k) Report. “K090306: Aragon Surgical RF System L2 Instrument.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090306
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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